Clinical trial • Phase III • Cardiology

OMECAMTIV MECARBIL for Heart failure with reduced ejection fraction

Phase III trial of OMECAMTIV MECARBIL for Heart failure with reduced ejection fraction.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Heart failure with reduced ejection fraction
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
19-02-2025
First CTIS Authorization Date
03-06-2025

Trial design

Randomised, matching placebo — placebo administered twice daily (participants will receive placebo twice daily).-controlled, adaptive Phase III trial in Spain, Greece, Poland and others.

Randomised
Yes
Comparator
Matching Placebo — placebo administered twice daily (participants will receive placebo twice daily).
Adaptive
True, elements: run-in period where all participants receive omecamtiv mecarbil 25 mg twice daily for 2 weeks with steady-state plasma concentration assessment; 2-week placebo washout prior to randomization; dosing at randomization assigned based on omecamtiv mecarbil plasma concentration (participants will receive 25, 37.5 or 50 mg twice daily); event-driven stopping rule: participants will continue on study treatment until 850 participants experience a HF event or CV death.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
1280

Eligibility

Recruits 1280 Vulnerable population selected (isVulnerablePopulationSelected = true). The provided CTIS record does not include detailed text on assent/consent handling for vulnerable participants; informed consent forms are supplied (see documents) but no specific assent procedures are described in the available fields..

Pregnancy Exclusion
Are pregnant or planning pregnancy during the study period, or planning to breastfeed during treatment with IP or within 5 days after the end of treatment with IP
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). The provided CTIS record does not include detailed text on assent/consent handling for vulnerable participants; informed consent forms are supplied (see documents) but no specific assent procedures are described in the available fields.

Inclusion criteria

  • {"criterion_text":"- Are between ≥ 18 years and ≤ 85 years at the signing of informed consent\n- Have a history of chronic HFrEF, defined as requiring treatment for HF for a minimum of 3 months prior to screening\n- Are receiving oral loop diuretics on a regular schedule\n- Patients without AFF on screening ECG: LVEF < 30% within 6 months of screening\n- Patients without AFF on screening ECG: Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 1000 pg/mL (BNP ≥ 300 pg/mL)\n- Patients with AFF on screening ECG: LVEF < 25% within 6 months of screening\n- Patients with AFF on screening ECG: Elevated N-terminal prohormone of B-type natriuretic peptide (NT-proBNP) ≥ 3000 pg/mL (BNP ≥ 900 pg/mL)\n- Patients with AFF on screening ECG: Not currently taking digoxin\n- Meet one of the following criteria for a recent HF event: Are currently hospitalized with the primary reason of HF decompensation\n- Meet one of the following criteria for a recent HF event: Had an HF event (as defined in the primary endpoint) within 12 months prior to screening. For the purposes of a qualifying HF event, subcutaneous furosemide will be treated as equivalent to intravenous furosemide\n- Meet one of the following criteria for a recent HF event: Had outpatient escalation of oral diuretics due to worsening signs and symptoms of heart failure plus one of two additional criteria sustained for at least 1 week: (1) at least 50% or 1.5-fold increase in daily loop-diuretic–equivalent dose; (2) the addition of a new diuretic class to a loop diuretic\n- Are established on regional standard-of-care HF therapies for at least 30 days prior to screening\n- Systolic blood pressure ≤ 140 mmHg"}

Exclusion criteria

  • {"criterion_text":"- Have AFF on the screening ECG and are currently taking digoxin\n- Have had any event or procedure that may have resulted in a change in ejection fraction, including, but not limited to, acute coronary syndrome, and/or any coronary revascularization, cardiac surgery, valve surgery, cardiac resynchronization, or cardiac contractility modulation therapy within 3 months of screening\n- Are admitted to a long-term care facility or hospice\n- Have a projected survival of < 12 months due to non-cardiovascular causes based on clinical judgment\n- Are receiving intravenous inotropes or intravenous vasopressors ≤ 3 days prior to screening\n- Are receiving mechanical hemodynamic support or mechanical ventilation ≤ 7 days prior to screening\n- Are receiving intravenous diuretics, intravenous vasodilators, or supplemental oxygen therapy ≤ 12 hours prior to screening (except for nocturnal supplemental oxygen for sleep apnea or heart failure)\n- Have an estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m2 or receiving dialysis at screening\n- Have previously had a solid organ transplant\n- Are receiving treatment in another investigational device or drug study or are within 30 days of ending such investigational treatment at screening\n- Have received omecamtiv mecarbil in a previous clinical trial\n- Are pregnant or planning pregnancy during the study period, or planning to breastfeed during treatment with IP or within 5 days after the end of treatment with IP\n- Have primary infiltrative cardiomyopathy (e.g. cardiac amyloidosis) or severe stenotic valvular disease"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Time to the first event of the following components: •\tCV death •\tHF event","definition_or_measurement_approach":"Time-to-event composite endpoint defined as time from randomization to first occurrence of cardiovascular (CV) death or a heart failure (HF) event; analysed as a time-to-first-event outcome."}

Secondary endpoints

  • {"endpoint_text":"- 1. Time to first HF event, CV death, LVAD implantation/cardiac transplantation or stroke\n- 2. Time to the first HF hospitalization\n- 3. Time to the first HF event, CV death, LVAD implantation/cardiac transplant, or stroke in a subgroup of patients with severe heart failure (LVEF < 30%, NYHA class 3-4, HF event within the last 3 months)\n- 4. Time to the first event of the following components: CV death, LVAD implantation/cardiac transplantation, and strok\n- 5. Time to CV death\n- 6. Time to first event of stroke\n- 7. Time to all-cause death","definition_or_measurement_approach":"All listed secondary endpoints are time-to-event outcomes (time from randomization to first occurrence of the stated event). Subgroup analysis specified for endpoint 3 (severe HF: LVEF <30%, NYHA class 3-4, HF event within last 3 months)."}

Recruitment

Digital Remote Recruitment
True, digital/remote methods include a pre-screening data collection survey platform (Duke Clinical Research Institute responsibility) and electronic distribution of interest letters/flyers; site websites/press releases may be used for remote recruitment.
Planned Sample Size
1280
Recruitment Window Months
31
Consent Approach
Informed consent to be obtained from participants (adult population: ≥18 to ≤85 years). Multiple language versions of the main informed consent form and related ICFs are provided in the CTIS documents (examples: English, Spanish, Greek, Polish, Italian, French, German). Pregnancy-specific ICFs and optional-future-research ICF addenda are also provided. No assent procedures for minors are described (trial includes adults only).

Methods

  • Flyers / Patient flyers (country-specific versions: e.g. K2_CY-1033_Flyer_ITA_ita, K2_CY 1033_Flyer_FRA_fra, K2_CY-1033_Flyer_POL_pol) — channel: printed and/or digital flyers targeting prospective participants (country-specific).
  • Interest letters to prospective participants / community partners / referring providers (country-specific documents: e.g. Interest-Letter-to-Prospective-Participants_ITA, Interest-Letter-to-Community-Partners_ITA, Interest-Letter-to-Referring-Providers_ITA, K2_COMET-HF_Interest Letter to Prospective Participants_ell) — channel: mailed or emailed letters to potential participants or community/referring partners (country-specific).
  • GP letters (e.g. K2_CY 1033_GP Letter_ITA_IT_Public) — channel: letters to general practitioners to inform/referral (Italy example provided).
  • Site press release / website release (country-specific: e.g. K2_CY 1033_Site-Press-Release_ell, K2_CY 1033_Site-Press-or-website-Release_DEU_deu) — channel: site press releases and website postings to reach local patients/community.
  • Patient card and patient-facing materials (e.g. L2_CY 1033_Patient-Card_FR_French_Public) — channel: site-distributed patient cards/information.
  • Pre-screening data collection survey platform (documented duty: Duke Clinical Research Institute listed responsibility 'Pre-screening data collection survey platform') — channel: digital pre-screening platform to collect prospective participant information.

Geography

Total Number Of Sites
77
Total Number Of Participants
810

Spain

Earliest CTIS Part Ii Submission Date
14-05-2025
Latest Decision Or Authorization Date
28-07-2025
Processing Time Days
75
Number Of Sites
19
Number Of Participants
170

Sites

Site Name
Bellvitge University Hospital
Department Name
Cardiologia
Principal Investigator Name
Jose Gonzalez Costello
Principal Investigator Email
jgonzalez@bellvitgehospital.cat
Contact Person Name
Jose Gonzalez Costello
Site Name
Hospital Universitari Vall D Hebron
Department Name
Cardiologia
Principal Investigator Name
Ana Belen Mendez Fernandez
Principal Investigator Email
ana.mendez@vallhebron.cat
Contact Person Name
Ana Belen Mendez Fernandez
Contact Person Email
ana.mendez@vallhebron.cat
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Cardiologia
Principal Investigator Name
Luis Almenar Bonet
Principal Investigator Email
lualmenar@gmail.com
Contact Person Name
Luis Almenar Bonet
Contact Person Email
lualmenar@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Cardiologia
Principal Investigator Name
José Raúl Moreno-Gómez
Principal Investigator Email
raulmorenog@hotmail.com
Contact Person Name
José Raúl Moreno-Gómez
Contact Person Email
raulmorenog@hotmail.com
Site Name
Hospital San Juan de la Cruz
Department Name
Medicina Interna (Unidad de Fallo Cardiaco)
Principal Investigator Name
Juan Luis Bonilla Palomas
Principal Investigator Email
juanl.bonilla.sspa@juntadeandalucia.es
Contact Person Name
Juan Luis Bonilla Palomas
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Cardiologia
Principal Investigator Name
Pablo Garcia Pavia
Principal Investigator Email
pablogpavia@yahoo.es
Contact Person Name
Pablo Garcia Pavia
Contact Person Email
pablogpavia@yahoo.es
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Cardiologia
Principal Investigator Name
Julio Nuñez Villota
Principal Investigator Email
yulnunez@gmail.com
Contact Person Name
Julio Nuñez Villota
Contact Person Email
yulnunez@gmail.com
Site Name
Hospital Alvaro Cunqueiro
Department Name
Cardiologia
Principal Investigator Name
Victor Alfonso Jimenez Diaz
Principal Investigator Email
victor.alfonso.jimenz.diaz@sergas.es
Contact Person Name
Victor Alfonso Jimenez Diaz
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Cardiologia (Unidad de IC Avanzada y Trasplante Cardíaco)
Principal Investigator Name
Maria Generosa Crespo-Leiro
Principal Investigator Email
marisacrespo@gmail.com
Contact Person Name
Maria Generosa Crespo-Leiro
Contact Person Email
marisacrespo@gmail.com
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Cardiologia
Principal Investigator Name
Fernando Woner Diz
Principal Investigator Email
fworner.lleida.ics@gencat.cat
Contact Person Name
Fernando Woner Diz
Contact Person Email
fworner.lleida.ics@gencat.cat
Site Name
Hospital Universitari Joan XXIII De Tarragona
Department Name
Cardiologia
Principal Investigator Name
Jose Luis Ferreiro Gutierrez
Principal Investigator Email
jferreiro.hj23.ics@gencat.cat
Contact Person Name
Jose Luis Ferreiro Gutierrez
Contact Person Email
jferreiro.hj23.ics@gencat.cat
Site Name
Complexo Hospitalario Universitario De Santiago
Department Name
Cardiologia
Principal Investigator Name
Jose Ramon Gonzalez Juanatey
Principal Investigator Email
jose.ramon.gonzalez.juanatey@sergas.es
Contact Person Name
Jose Ramon Gonzalez Juanatey
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Cardiología
Principal Investigator Name
Domingo Andrés Pascual Figal
Principal Investigator Email
domingoa.pascual@carm.es
Contact Person Name
Domingo Andrés Pascual Figal
Contact Person Email
domingoa.pascual@carm.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Cardiologia (Unidad de IC Avanzada y Trasplante Cardíaco)
Principal Investigator Name
Diego Rangel Sousa
Principal Investigator Email
diegorangelsousa@yahoo.es
Contact Person Name
Diego Rangel Sousa
Contact Person Email
diegorangelsousa@yahoo.es
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Cardiologia
Principal Investigator Name
José Manuel Garcia Pinilla
Principal Investigator Email
pinilla@secardiologia.es
Contact Person Name
José Manuel Garcia Pinilla
Contact Person Email
pinilla@secardiologia.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Cardiología
Principal Investigator Name
Sonia Mirabet Perez
Principal Investigator Email
SMirabet@santpau.cat
Contact Person Name
Sonia Mirabet Perez
Contact Person Email
SMirabet@santpau.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Cardiologia
Principal Investigator Name
Maria Dolores Garcia-Cosio Carmena
Principal Investigator Email
lolagcosio@gmail.com
Contact Person Name
Maria Dolores Garcia-Cosio Carmena
Contact Person Email
lolagcosio@gmail.com
Site Name
Hospital Universitario De Salamanca
Department Name
Cardiologia
Principal Investigator Name
Luis Miguel Rincon Díaz
Principal Investigator Email
lmrincond@saludcastillayleon.es
Contact Person Name
Luis Miguel Rincon Díaz
Site Name
Hospital Universitario Lucus Augusti
Department Name
Cardiologia
Principal Investigator Name
Carlos Gonzalez Juanatey
Principal Investigator Email
Carlos.Gonzalez.Juanatey@sergas.es
Contact Person Name
Carlos Gonzalez Juanatey

Greece

Earliest CTIS Part Ii Submission Date
06-03-2025
Latest Decision Or Authorization Date
29-04-2026
Processing Time Days
419
Number Of Sites
10
Number Of Participants
150

Sites

Site Name
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara
Department Name
2nd University Department of Cardiology
Principal Investigator Name
Gerasimos Filippatos
Principal Investigator Email
gfilippatos@gmail.com
Contact Person Name
Gerasimos Filippatos
Contact Person Email
gfilippatos@gmail.com
Site Name
Hippokration Hospital
Department Name
1st University department of Cardiology
Principal Investigator Name
Christina Chrysochoou
Principal Investigator Email
chrysohoou@usa.net
Contact Person Name
Christina Chrysochoou
Contact Person Email
chrysohoou@usa.net
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
A’ University Cardiology Clinic
Principal Investigator Name
Antonios Ziakas
Principal Investigator Email
tonyziakas@hotmail.com
Contact Person Name
Antonios Ziakas
Contact Person Email
tonyziakas@hotmail.com
Site Name
General Hospital Of Athens G Gennimatas
Department Name
Heart Failure Unit, Cardiology Department
Principal Investigator Name
Apostolos Karavidas
Principal Investigator Email
akaravid@yahoo.com
Contact Person Name
Apostolos Karavidas
Contact Person Email
akaravid@yahoo.com
Site Name
General Hospital Of Thessaloniki Papageorgiou
Department Name
2nd Department of Cardiology
Principal Investigator Name
Ioannis Styliadis
Principal Investigator Email
ioannisstyliadis@hotmail.com
Contact Person Name
Ioannis Styliadis
Contact Person Email
ioannisstyliadis@hotmail.com
Site Name
General University Hospital Of Larissa
Department Name
University Cardiology Clinic
Principal Investigator Name
Gregory Giamouzis
Principal Investigator Email
grgiamouzis@gmail.com
Contact Person Name
Gregory Giamouzis
Contact Person Email
grgiamouzis@gmail.com
Site Name
General Hospital Of Nea Ionia Konstantopouleio Patision
Department Name
Cardiology Department
Principal Investigator Name
Sotirios Patsilinakos
Principal Investigator Email
spatsilinakos@gmail.com
Contact Person Name
Sotirios Patsilinakos
Contact Person Email
spatsilinakos@gmail.com
Site Name
General Hospital Of Chalkida
Department Name
Cardiology Clinic
Principal Investigator Name
Konstantina Toli
Principal Investigator Email
d_toli@yahoo.gr
Contact Person Name
Konstantina Toli
Contact Person Email
d_toli@yahoo.gr
Site Name
University General Hospital Of Alexandroupoli
Department Name
Cardiology Clinic
Principal Investigator Name
Dimitrios Tziakas
Principal Investigator Email
dtziakas@med.duth.gr
Contact Person Name
Dimitrios Tziakas
Contact Person Email
dtziakas@med.duth.gr
Site Name
Asklepieion Voulas General Hospital
Department Name
Department of Cardiology
Principal Investigator Name
Leonidas Poulimenos
Principal Investigator Email
leonp@otenet.gr
Contact Person Name
Leonidas Poulimenos
Contact Person Email
leonp@otenet.gr

Poland

Earliest CTIS Part Ii Submission Date
13-05-2025
Latest Decision Or Authorization Date
05-05-2026
Processing Time Days
357
Number Of Sites
13
Number Of Participants
150

Sites

Site Name
Tomasz Blicharski Lubelskie Centrum Diagnostyczne
Principal Investigator Name
Tomasz Blicharski
Principal Investigator Email
blicharski@vp.pl
Contact Person Name
Tomasz Blicharski
Contact Person Email
blicharski@vp.pl
Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Kardiologii z OINK
Principal Investigator Name
Agnieszka Tycińska
Principal Investigator Email
agnieszka.tycinska@gmail.com
Contact Person Name
Agnieszka Tycińska
Contact Person Email
agnieszka.tycinska@gmail.com
Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Uniwersytecki Ośrodek Wczesnych Faz
Principal Investigator Name
Ewa Straburzyńska-Migaj
Principal Investigator Email
ewa.straburzynska-migaj@skpp.edu.pl
Contact Person Name
Ewa Straburzyńska-Migaj
Site Name
Szpital Sw Anny W Miechowie
Department Name
Oddział Kardiologii i Chorób Wewnętrznych
Principal Investigator Name
Mariusz Kafara
Principal Investigator Email
kafaram@interia.pl
Contact Person Name
Mariusz Kafara
Contact Person Email
kafaram@interia.pl
Site Name
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
I Katedra i Klinika Kardiologii
Principal Investigator Name
Krzysztof Ozierański
Principal Investigator Email
krzysztof.ozieranski@gmail.com
Contact Person Name
Krzysztof Ozierański
Contact Person Email
krzysztof.ozieranski@gmail.com
Site Name
Poradnia Aka-Med Centrum Sp. z o.o.
Principal Investigator Name
Janusz Spyra
Principal Investigator Email
aszymspyra4@interia.pl
Contact Person Name
Janusz Spyra
Contact Person Email
aszymspyra4@interia.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 2 Uniwersytetu Medycznego W Lodzi SPZOZ
Department Name
Zakład Kardiologii Nieinwazyjnej, Poradnia Kardiologiczna
Principal Investigator Name
Małgorzata Lelonek
Principal Investigator Email
malgorzata.lelonek@umed.lodz.pl
Contact Person Name
Małgorzata Lelonek
Site Name
Uniwersytecki Szpital Kliniczny W Opolu
Department Name
Oddział Kardiologii z Pododdziałem Interwecji Sercowo-Naczyniowych
Principal Investigator Name
Marek Gierlotka
Principal Investigator Email
marek.gierlotka@gmail.com
Contact Person Name
Marek Gierlotka
Contact Person Email
marek.gierlotka@gmail.com
Site Name
Balsammedica Sp. z o.o.
Principal Investigator Name
Łukasz Januszkiewicz
Principal Investigator Email
lukasz.jan.januszkiewicz@gmail.com
Contact Person Name
Łukasz Januszkiewicz
Site Name
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
Department Name
Oddział Szybkiej Diagnostyki
Principal Investigator Name
Małgorzata Konieczyńska
Principal Investigator Email
mkonieczynska@szpitaljp2.krakow.pl
Contact Person Name
Małgorzata Konieczyńska
Site Name
4 Wojskowy Szpital Kliniczny z Polikliniką SP ZOZ we Wrocławiu
Department Name
Klinika Kardiologii, Ośrodek Chorób Serca
Principal Investigator Name
Bartosz Krakowiak
Principal Investigator Email
bartek.krakowiak@gmail.com
Contact Person Name
Bartosz Krakowiak
Contact Person Email
bartek.krakowiak@gmail.com
Site Name
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Department Name
Oddział Kliniczny Kardiologii i Intensywnej Terapii Kardiologicznej
Principal Investigator Name
Grzegorz Skonieczny
Principal Investigator Email
grzegorz.skonieczny@onet.eu
Contact Person Name
Grzegorz Skonieczny
Contact Person Email
grzegorz.skonieczny@onet.eu
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Department Name
II Klinika Kardiologii
Principal Investigator Name
Jarosław Drożdż
Principal Investigator Email
jaroslaw.drozdz@umed.lodz.pl
Contact Person Name
Jarosław Drożdż
Contact Person Email
jaroslaw.drozdz@umed.lodz.pl

Italy

Earliest CTIS Part Ii Submission Date
24-04-2025
Latest Decision Or Authorization Date
30-04-2026
Processing Time Days
371
Number Of Sites
10
Number Of Participants
80

Sites

Site Name
Ospedale San Raffaele S.r.l.
Department Name
Cardiologia
Principal Investigator Name
Giorgio Bassanelli
Principal Investigator Email
bassanelli.giorgio@hsr.it
Contact Person Name
Giorgio Bassanelli
Contact Person Email
bassanelli.giorgio@hsr.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Cardiology
Principal Investigator Name
Samuela Carigi
Principal Investigator Email
samuela.carigi@auslromagna.it
Contact Person Name
Samuela Carigi
Contact Person Email
samuela.carigi@auslromagna.it
Site Name
Multimedica S.p.A.
Department Name
Unit of Cardiology
Principal Investigator Name
Francesco Bandera
Principal Investigator Email
Francesco.Bandera@multimedica.it
Contact Person Name
Francesco Bandera
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
SC Cardiologia 1, Cardiovascular Department
Principal Investigator Name
Michele Senni
Principal Investigator Email
msenni@asst-pg23.it
Contact Person Name
Michele Senni
Contact Person Email
msenni@asst-pg23.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
SC Cardiologia
Principal Investigator Name
Riccardo Maria Inciardi
Principal Investigator Email
riccardo.inciardi@asst-spedalicivili.it
Contact Person Name
Riccardo Maria Inciardi
Site Name
Hospital Santa Maria Della Misericordia
Department Name
Department of Medicine and Surgery
Principal Investigator Name
Erberto Carluccio
Principal Investigator Email
erberto.carluccio@unipg.it
Contact Person Name
Erberto Carluccio
Contact Person Email
erberto.carluccio@unipg.it
Site Name
Centro Cardiologico Monzino S.p.A.
Department Name
UO Scompenso Cardiaco Cardiologia Clinica e Riabilitativa
Principal Investigator Name
Piergiuseppe Agostoni
Principal Investigator Email
piergiuseppe.agostoni@unimi.it
Contact Person Name
Piergiuseppe Agostoni
Contact Person Email
piergiuseppe.agostoni@unimi.it
Site Name
University Hospital Of Ferrara
Department Name
Cardiology
Principal Investigator Name
Alessandro Fucili
Principal Investigator Email
afucili@ospefe.it
Contact Person Name
Alessandro Fucili
Contact Person Email
afucili@ospefe.it
Site Name
Azienda Unita Locale Socio Sanitaria N 8 Berica
Department Name
U.O.C. Cardiologia (Ovest)
Principal Investigator Name
Claudio Bilato
Principal Investigator Email
claudio.bilato@aulss8.veneto.it
Contact Person Name
Claudio Bilato
Site Name
Irccs San Raffaele Roma S.r.l.
Department Name
Cardiology
Principal Investigator Name
Maurizio Volterrani
Principal Investigator Email
maurizio.volterrani@sanraffaele.it
Contact Person Name
Maurizio Volterrani

Germany

Earliest CTIS Part Ii Submission Date
05-04-2025
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
388
Number Of Sites
14
Number Of Participants
140

Sites

Site Name
HELIOS Klinikum Erfurt GmbH
Department Name
Universitärer Campus Health and Medical University Erfurt 3. Medizinische Klinik
Principal Investigator Name
Alexander Lauten
Principal Investigator Email
Alexander.Lauten@helios-gesundheit.de
Contact Person Name
Alexander Lauten
Site Name
Universitaetsklinikum Jena KöR
Department Name
Klinik für Innere Medizin I
Principal Investigator Name
Julian Westphal
Principal Investigator Email
Julian.Westphal@med.uni-jena.de
Contact Person Name
Julian Westphal
Site Name
Universitaet Des Saarlandes
Department Name
Klinisches Studienzentrum der Innere Medizin III
Principal Investigator Name
Ingrid Kindermann
Principal Investigator Email
ingrid.kindermann@uks.eu
Contact Person Name
Ingrid Kindermann
Contact Person Email
ingrid.kindermann@uks.eu
Site Name
Goethe University Frankfurt
Department Name
Universitäres Herz- und Gefäßzentrum Frankfurt
Principal Investigator Name
Maria Papathanasiou
Principal Investigator Email
Maria.Papathanasiou@unimedizin-ffm.de
Contact Person Name
Maria Papathanasiou
Site Name
Praxis für Kardiologie
Principal Investigator Name
Jens Taggesselle
Principal Investigator Email
dr.taggeselle@web.de
Contact Person Name
Jens Taggesselle
Contact Person Email
dr.taggeselle@web.de
Site Name
Marienhaus Klinikum Mainz GmbH
Department Name
Innere Medizin I, Kardiologie
Principal Investigator Name
Sabine Genth-Zotz
Principal Investigator Email
Sabine.Genth-Zotz@marienhaus.de
Contact Person Name
Sabine Genth-Zotz
Site Name
LMU Klinikum Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Stefan Kääb
Principal Investigator Email
stefan.kaab@med.uni-muenchen.de
Contact Person Name
Stefan Kääb
Site Name
Universitaetsklinikum Heidelberg AöR
Department Name
Clinic for Cardiology, Angiology and Pneumology
Principal Investigator Name
Benjamin Meder
Principal Investigator Email
Benjamin.Meder@med.uni-heidelberg.de
Contact Person Name
Benjamin Meder
Site Name
University Medical Center Hamburg-Eppendorf
Department Name
Universitäres Herz- und Gefäßzentrum Hamburg Klinik und Poliklinik für Kardiologie
Principal Investigator Name
Christina Magnussen
Principal Investigator Email
c.magnussen@uke.de
Contact Person Name
Christina Magnussen
Contact Person Email
c.magnussen@uke.de
Site Name
Universitaetsklinikum Bonn AöR
Department Name
Medizinische Klinik und Poliklinik II, Herzzentrum, Kardiologische Studienambulanz
Principal Investigator Name
Can Öztürk
Principal Investigator Email
can.oeztuerk@ukbonn.de
Contact Person Name
Can Öztürk
Contact Person Email
can.oeztuerk@ukbonn.de
Site Name
Universitaetsklinikum Wuerzburg AöR
Department Name
Deutsches Zentrum für Herzinsuffizienz Würzburg
Principal Investigator Name
Stefan Störk
Principal Investigator Email
Stoerk_S@ukw.de
Contact Person Name
Stefan Störk
Contact Person Email
Stoerk_S@ukw.de
Site Name
Asklepios Kliniken Langen-Seligenstadt GmbH
Department Name
Medizinische Klinik 1 / Kardiologie, Angiologie und Internistische Intensivmedizin
Principal Investigator Name
Marcus Mittag
Principal Investigator Email
m.mittag@asklepios.com
Contact Person Name
Marcus Mittag
Contact Person Email
m.mittag@asklepios.com
Site Name
Universitaetsmedizin Goettingen
Department Name
Herzzentrum Göttingen
Principal Investigator Name
Stephan von Haehling
Principal Investigator Email
stephan.von.haehling@med.uni-goettingen.de
Contact Person Name
Stephan von Haehling
Site Name
Kerckhoff-Klinik GmbH
Department Name
Admin. Forschung und Lehre
Principal Investigator Name
Andreas Rieth
Principal Investigator Email
A.Rieth@kerckhoff-klinik.de
Contact Person Name
Andreas Rieth
Contact Person Email
A.Rieth@kerckhoff-klinik.de

France

Earliest CTIS Part Ii Submission Date
08-04-2025
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
385
Number Of Sites
11
Number Of Participants
120

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Cardiology
Principal Investigator Name
Damien LOGEART
Principal Investigator Email
damien.logeart@aphp.fr
Contact Person Name
Damien LOGEART
Contact Person Email
damien.logeart@aphp.fr
Site Name
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Department Name
Cardiology
Principal Investigator Name
Jean-Michel TARTIERE
Principal Investigator Email
jean-michel.tartiere@ch-toulon.fr
Contact Person Name
Jean-Michel TARTIERE
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Cardiology
Principal Investigator Name
Muriel SALVAT
Principal Investigator Email
msalvat@chu-grenoble.fr
Contact Person Name
Muriel SALVAT
Contact Person Email
msalvat@chu-grenoble.fr
Site Name
Centre Hospitalier Universitaire De Rennes
Department Name
Service de cardiologie et maladies vasculaires
Principal Investigator Name
Erwan DONAL
Principal Investigator Email
erwan.donal@chu-rennes.fr
Contact Person Name
Erwan DONAL
Contact Person Email
erwan.donal@chu-rennes.fr
Site Name
Assistance Publique Hopitaux De Paris (Bichat Hospital)
Department Name
Bichat Hospital Cardiology
Principal Investigator Name
Guillaume JONDEAU
Principal Investigator Email
Guillaume.jondeau@aphp.fr
Contact Person Name
Guillaume JONDEAU
Contact Person Email
Guillaume.jondeau@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Cardiology
Principal Investigator Name
Albert HAGEGE
Principal Investigator Email
albert.hagege@aphp.fr
Contact Person Name
Albert HAGEGE
Contact Person Email
albert.hagege@aphp.fr
Site Name
L'Hopital Prive Du Confluent
Department Name
Interventional Cardiology and Care Unit
Principal Investigator Name
Jean-Pierre GUEFFET
Principal Investigator Email
jeanpierre.gueffet@groupeconfluent.fr
Contact Person Name
Jean-Pierre GUEFFET
Site Name
Hospices Civils De Lyon
Department Name
Heart Failure and Heart Transplant and the Cardiovascular Intensive Care Unit
Principal Investigator Name
Flora Kochly
Principal Investigator Email
flora.kochly@chu-lyon.fr
Contact Person Name
Flora Kochly
Contact Person Email
flora.kochly@chu-lyon.fr
Site Name
Polyclinique Vauban
Department Name
Cardiology
Principal Investigator Name
Sébastien CAUDMONT
Principal Investigator Email
sebastien.caudmont@elsan.care
Contact Person Name
Sébastien CAUDMONT
Contact Person Email
sebastien.caudmont@elsan.care
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Cardiology
Principal Investigator Name
François ROUBILLE
Principal Investigator Email
f-roubille@chu-montpellier.fr
Contact Person Name
François ROUBILLE
Contact Person Email
f-roubille@chu-montpellier.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Cardiology
Principal Investigator Name
Michel GALINIER
Principal Investigator Email
galinier.m@chu-toulouse.fr
Contact Person Name
Michel GALINIER
Contact Person Email
galinier.m@chu-toulouse.fr

Sponsor

Primary sponsor

Full Name
Cytokinetics Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Global Ltd.
Responsibilities
Clinical trial-related services in Greece
Name
PPD Development LP
Responsibilities
Site Payments and Reimbursement Management; site and trial management duties
Name
Everest Clinical Research Corporation
Name
Medgenesis Limited
Responsibilities
Software platform for Adverse Reaction Assessment with data integration
Name
Duke Clinical Research Institute
Responsibilities
Clinical Event Committee and Data Monitoring Board Management; Pre-screening data collection survey platform
Name
Medidata Solutions Inc.
Name
Primevigilance USA Inc.
Name
Fisher Clinical Services GmbH
Responsibilities
EU QP
Name
Cisys Inc.
Responsibilities
Clinical Event Committee database
Name
Azenta US Inc.
Responsibilities
Long term storage (Future Research for leftover samples)
Name
Scout Clinical
Responsibilities
Patient reimbursement

Third parties

  • {"country":"United Kingdom","full_name":"Medgenesis Limited","duties_or_roles":"Software platform for for Adverse Reaction Assessment with data integration","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Clinical trial-related services in Greece","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Everest Clinical Research Corporation","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"Cytokinetics.PV@primevigilance.com (pharmacovigilance related duties; sponsor duties code present)","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"EU QP","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Long term storage (Future Research for leftover samples)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Site Payments and Reimbursement Management; multiple clinical trial management duties","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Duke Clinical Research Institute","duties_or_roles":"Clinical Event Committee and Data Monitoring Board Management; Pre-screening data collection survey platform","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Cisys Inc.","duties_or_roles":"Clinical Event Committee database","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Omecamtiv Mecarbil
Active Substance
OMECAMTIV MECARBIL
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised
Starting Dose
Omecamtiv mecarbil 25 mg twice daily (run-in)
Dose Levels
25 mg, 37.5 mg, 50 mg (each administered twice daily)
Frequency
Twice daily
Maximum Dose
100 mg per day
Dose Escalation Increase
Initial 25 mg twice daily; subsequent possible doses 37.5 mg twice daily and 50 mg twice daily
Investigational Product Name
Matching Placebo
Modality
Other
Starting Dose
Placebo twice daily
Dose Levels
Placebo twice daily
Frequency
Twice daily

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