Clinical trial • Phase III • Cardiology

LEVOSIMENDAN for Pulmonary hypertension | Heart failure with preserved ejection fraction (HFpEF)

Phase III trial of LEVOSIMENDAN for Pulmonary hypertension | Heart failure with preserved ejection fraction (HFpEF).

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Pulmonary hypertension | Heart failure with preserved ejection fraction (HFpEF)
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-11-2025
First CTIS Authorization Date
24-03-2026

Trial design

Randomised, levosimendan (tnx-103), oral hard gelatin capsule versus placebo (the levosimendan placebo drug product is an immediate-release dosage form for oral administration). dose and schedule not specified in the provided data.-controlled Phase III trial in Austria, France, Germany and others.

Randomised
Yes
Comparator
Levosimendan (TNX-103), oral hard gelatin capsule versus placebo (the levosimendan placebo drug product is an immediate-release dosage form for oral administration). Dose and schedule not specified in the provided data.
Target Sample Size
250
Trial Duration For Participant
182

Eligibility

Recruits 250 The CTIS record indicates isVulnerablePopulationSelected = true. Informed consent is required from adult participants (age eligibility ≥18 years). Subject information and informed consent forms (ICFs) are provided in multiple country/language-specific versions (examples in German, French, Spanish, Italian, Polish, Bulgarian, Hungarian, Czech). No specific wording about assent or consent for minors is present in the provided data (minors are excluded by the age criterion)..

Vulnerable Population
The CTIS record indicates isVulnerablePopulationSelected = true. Informed consent is required from adult participants (age eligibility ≥18 years). Subject information and informed consent forms (ICFs) are provided in multiple country/language-specific versions (examples in German, French, Spanish, Italian, Polish, Bulgarian, Hungarian, Czech). No specific wording about assent or consent for minors is present in the provided data (minors are excluded by the age criterion).

Inclusion criteria

  • {"criterion_text":"- 1. Men or women, ≥18 to 85 years of age.\n- 2. NYHA Class II or III or ambulatory NYHA Class IV symptoms.\n- 3. A diagnosis of WHO Group 2 PH-HFpEF with qualifying hemodynamics verified by right heart catheterization\n- 4. A qualifying echocardiogram performed within 45 days of Day 1 (ie within the Screening Period) showing a left ventricular ejection fraction ≥40%.\n- 5. Documentation of the absence of pulmonary thromboembolism by ventilation-perfusion scan, computed tomography pulmonary angiogram, or pulmonary angiography performed within 45 days of Day 1.\n- 6. A qualifying 6-MWD of at least 100 meters, but not more than 450 meters at Screening (within 45 days of Day 1) AND at the baseline 6-Minute Walk Test (6-MWT) on Day 1."}

Exclusion criteria

  • {"criterion_text":"- 1. A diagnosis of PH WHO Groups 1, 3, 4, or 5.\n- 2. Echocardiographic evidence for hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy.\n- 3. Structural heart repair or replacement of the aortic valve or mitral valve within the past 24 months. OR, planned valve intervention in the next 24 months. OR, the presence of echocardiographic findings of significant valve disease as assessed from the qualifying echocardiogram and defined as: a. Mitral valve disease grade ≥3 mitral regurgitation or ≥moderate mitral stenosis. b. Aortic valve disease grade ≥2 aortic regurgitation or ≥moderate aortic stenosis\n- 4. Any of the following clinical laboratory values within 45 days of Day 1 as specified: a. Hemoglobin <10 g/dL. b. Serum ALT or AST levels >3×ULN or total bilirubin >3×ULN. c. ECG with a heart rate-corrected QT interval using Fridericia’s formula >450 msec for males and >470 msec for females at Screening in the absence of a bundle branch block or ventricularly paced rhythm. d. Platelet count <75,000/mm3.\n- 5. Any of the following structural conditions that may compromise pulmonary function: a. Congenital abnormalities of the lungs, thorax or diaphragm, that may significantly contribute to the severity of PH in the opinion of the Investigator. b. A full or partial pneumonectomy. c. Previous therapeutic radiation of lungs or mediastinum.\n- 6. Recent documentation of significant underlying lung disease.\n- 7. Documentation of pulmonary thromboembolism in the last 12 months by a ventilation-perfusion scan, CT pulmonary angiogram, or a pulmonary angiography with an interpretation other than a normal or low probability result.\n- 8. Cardiovascular comorbidities, which include the following: a. Symptomatic or untreated coronary artery disease. b. Acute coronary syndrome, coronary artery bypass graft, or percutaneous coronary intervention; any within 180 days of Day 1. c. Uncontrolled resting heart rate due to atrial fibrillation or atrial flutter at the time of the Screening ambulatory cardiac monitoring. d. History of untreated serious life-threatening or hemodynamically significant arrhythmia. e. History of or anticipated heart transplant or ventricular assist device implantation. f. Anticipated implantation of a pacemaker, or pacemaker implantation within 30 days of Screening. g. Occurrence of myocardial infarction due to epicardial coronary artery disease within 180 days of Day 1. h. Uncontrolled systemic hypertension as evidenced by sitting systolic BP >170 mmHg after a period of rest during the Screening Period. i. Stroke within 90 days of Day 1. j. Systolic BP <100 mmHg at Screening and Day 1."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Efficacy: Change from baseline in 6-MWD (Day 1 to Week 26). Safety: Incidence of AEs, SAEs, physical examinations, vital signs, clinical laboratory values, ECGs, heart rate and rhythm as determined by cardiac monitoring and AESI (Day 1 to Week 26)","definition_or_measurement_approach":"Efficacy measured as change from baseline in 6-Minute Walk Distance (6-MWD) from Day 1 to Week 26. Safety measured by incidence of adverse events (AEs), serious adverse events (SAEs), physical examinations, vital signs, clinical laboratory values, ECGs, heart rate and rhythm via cardiac monitoring and AESI from Day 1 to Week 26."}

Secondary endpoints

  • {"endpoint_text":"- 1. Change in KCCQ-TSS (Day 1 to Week 26).","definition_or_measurement_approach":"Change in Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) from Day 1 to Week 26."}
  • {"endpoint_text":"- 2. Number of Clinical Worsening Events (Day 1 to Week 26). Clinical Worsening Events are defined as: a. Unplanned hospitalization due to a cardiopulmonary indication OR Urgent outpatient visits for the administration of IV diuretics. b. Deaths (caused by clinical conditions directly related to cardiovascular events).","definition_or_measurement_approach":"Count of clinical worsening events from Day 1 to Week 26; events defined as unplanned cardiopulmonary hospitalizations or urgent outpatient IV diuretics administration, and deaths due to cardiovascular-related clinical conditions."}
  • {"endpoint_text":"- 3. Time to first occurrence of a Clinical Worsening Event (Day 1 to Week 26).","definition_or_measurement_approach":"Time-to-event analysis measuring time from Day 1 to first clinical worsening event up to Week 26."}
  • {"endpoint_text":"- 4. Change in NYHA Functional Class (Day 1 to Week 26).","definition_or_measurement_approach":"Change in New York Heart Association (NYHA) functional class from Day 1 to Week 26."}

Recruitment

Registry Or Advocacy Recruitment
True, Fondazione Toscana Gabriele Monasterio (listed as a Patient organisation/association among Italian trial sites)
Digital Remote Recruitment
True, remote methods include telephone pre-ICF screening calls, welcome and check-in call scripts, email communications, and ePatch/remote participant guides documented in country-specific subject material.
Planned Sample Size
250
Recruitment Window Months
33
Consent Approach
Informed consent is provided by participants (adults ≥18 years). Country- and language-specific subject information and informed consent forms (ICFs) are provided (documents available in German, French, Spanish, Italian, Polish, Bulgarian, Hungarian, Czech and bilingual placeholders). Pre-ICF telephone data collection and Scout clinical pre-ICF procedures are documented, indicating an initial telephone contact prior to formal consent. No assent procedures for minors are described (minors excluded by age criterion).

Methods

  • Site-based recruitment via participating hospitals/clinics listed per country (hospital/clinic investigator sites).
  • Telephone pre-ICF screening / 'Scout Clinical Pre ICF and Telephone Data Collection' documented in subject information materials.
  • Use of recruitment materials: patient posters, patient brochures, welcome booklets, and other printed recruitment material (country-specific K2 recruitment materials present, e.g., Czech patient poster/brochure).
  • Remote contact and communications: welcome and check-in call scripts, email communications to potential participants, and telephone contact per site materials.
  • Country-specific recruitment documents (K1) exist for multiple countries (examples: K1_DE_Recruitment Procedure, K1_FR_Recruitment Procedure, K1_IT_Recruitment Procedure, K1_ES_Recruitment Procedure, K1_PL_Recruitment Procedure_Polish, K1_BG_Recruitment Procedure_Bulgarian, K1_CZ_Recruitment Procedure_Bilingual).

Geography

Total Number Of Sites
51
Total Number Of Participants
319

Austria

Earliest CTIS Part Ii Submission Date
18-03-2026
Latest Decision Or Authorization Date
30-03-2026
Processing Time Days
12
Number Of Sites
5
Number Of Participants
19

Sites

Site Name
Klinik Favoriten
Department Name
Department of Cardiology
Principal Investigator Name
Diana Bonderman
Principal Investigator Email
diana.bonderman@gesundheitsverbund.at
Contact Person Name
Diana Bonderman
Site Name
Medical University Of Graz
Department Name
Clinical Department of Cardiology
Principal Investigator Name
Dirk von Lewinski
Principal Investigator Email
dirk.von-lewinski@medunigraz.at
Contact Person Name
Dirk von Lewinski
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
Department of Cardiology
Principal Investigator Name
Helena Schramm
Principal Investigator Email
Helena.Schramm@stpoelten.lknoe.at
Contact Person Name
Helena Schramm
Site Name
A.O. Krankenhaus St. Josef Braunau GmbH
Department Name
Department of Cardiology
Principal Investigator Name
Johann Auer
Principal Investigator Email
Johann.auer@khbr.at
Contact Person Name
Johann Auer
Contact Person Email
Johann.auer@khbr.at
Site Name
Klinikum Klagenfurt Am Wörthersee
Department Name
Department of Cardiology
Principal Investigator Name
Hannes Alber
Principal Investigator Email
hannes.alber@kabeg.at
Contact Person Name
Hannes Alber
Contact Person Email
hannes.alber@kabeg.at

France

Earliest CTIS Part Ii Submission Date
05-12-2025
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
132
Number Of Sites
5
Number Of Participants
34

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Cardiologie
Principal Investigator Name
Emile FERRARI
Principal Investigator Email
Ferrari.e@chu-nice.fr
Contact Person Name
Emile FERRARI
Contact Person Email
Ferrari.e@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Unité de soins intensifs de Cardiologie
Principal Investigator Name
François ROUBILLE
Principal Investigator Email
f-roubille@chumontpellier.fr
Contact Person Name
François ROUBILLE
Contact Person Email
f-roubille@chumontpellier.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Cardiologie etMaladies Vasculaires
Principal Investigator Name
David STEVANT
Principal Investigator Email
David.stevant@chunantes.fr
Contact Person Name
David STEVANT
Contact Person Email
David.stevant@chunantes.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Cardiologie
Principal Investigator Name
Fabrice BAUER
Principal Investigator Email
Fabrice.bauer@aphp.fr
Contact Person Name
Fabrice BAUER
Contact Person Email
Fabrice.bauer@aphp.fr
Site Name
Centre Hospitalier De Pau
Department Name
Cardiologie
Principal Investigator Name
JeanFrancois RIVIERE
Principal Investigator Email
Jean-francois.riviere@chpau.fr
Contact Person Name
JeanFrancois RIVIERE
Contact Person Email
Jean-francois.riviere@chpau.fr

Germany

Earliest CTIS Part Ii Submission Date
13-03-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
14
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Kerckhoff-Klinik GmbH
Department Name
Cardiology
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
Site Name
University Medical Center Hamburg-Eppendorf
Principal Investigator Name
Peter Becher
Principal Investigator Email
m.becher@uke.de
Contact Person Name
Peter Becher
Contact Person Email
m.becher@uke.de
Site Name
BG Klinikum Unfallkrankenhaus Berlin gGmbH
Department Name
Klinik für Innere Medizin und Kardiologie
Principal Investigator Name
Katrin Barth
Principal Investigator Email
katrin.barth2@ukb.de
Contact Person Name
Katrin Barth
Contact Person Email
katrin.barth2@ukb.de
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Michael Halank
Principal Investigator Email
michael.halank@uniklinikumdresden.de
Contact Person Name
Michael Halank

Hungary

Earliest CTIS Part Ii Submission Date
04-03-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
23
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Central Hospital Of Northern Pest Military Hospital
Department Name
Cardiology Department
Principal Investigator Name
Gabor Zoltan Duray
Principal Investigator Email
duray.gabor@epc-honvedkorhaz.hu
Contact Person Name
Gabor Zoltan Duray
Site Name
University Of Debrecen
Department Name
Clinic of Cardiology and Cardiac Surgery
Principal Investigator Name
Attila Borbely
Principal Investigator Email
borbely.attila@med.unideb.hu
Contact Person Name
Attila Borbely
Contact Person Email
borbely.attila@med.unideb.hu
Site Name
University Of Szeged
Department Name
Family Medical Institute and Clinic
Principal Investigator Name
Gergely Ágoston
Principal Investigator Email
agoston.gergely@med.u-szeged.hu
Contact Person Name
Gergely Ágoston
Site Name
Semmelweis University
Department Name
Clinic of Heart and Vascular Medicine
Principal Investigator Name
Bela Merkely
Principal Investigator Email
merkely.bela@semmelweis.hu
Contact Person Name
Bela Merkely
Contact Person Email
merkely.bela@semmelweis.hu

Italy

Earliest CTIS Part Ii Submission Date
02-02-2026
Latest Decision Or Authorization Date
25-03-2026
Processing Time Days
51
Number Of Sites
8
Number Of Participants
85

Sites

Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
SC Cardiologia
Principal Investigator Name
Laura Scelsi
Principal Investigator Email
l.scelsi@smatteo.pv.it
Contact Person Name
Laura Scelsi
Contact Person Email
l.scelsi@smatteo.pv.it
Site Name
Humanitas Mirasole S.p.A.
Department Name
Humanitas Research Hospital Dipartimento Cardiovascolare Unità di Cardiologia clinica
Principal Investigator Name
Cristina Panico
Principal Investigator Email
cristina.panico@hunimed.eu
Contact Person Name
Cristina Panico
Contact Person Email
cristina.panico@hunimed.eu
Site Name
Ente Ecclesiastico Ospedale Generale Regionale Miulli
Department Name
UOC di Cardiologia e UTIC
Principal Investigator Name
Federico Quadrini
Principal Investigator Email
f.quadrini@miulli.it
Contact Person Name
Federico Quadrini
Contact Person Email
f.quadrini@miulli.it
Site Name
Fondazione Toscana Gabriele Monasterio
Department Name
Ospedale San Cataldo- Dipartimento Cardiotoracico UOC Cardiologia e medicina cardiovascolare
Principal Investigator Name
Michele Emdin
Principal Investigator Email
emdin@ftgm.it
Contact Person Name
Michele Emdin
Contact Person Email
emdin@ftgm.it
Site Name
Istituto Auxologico Italiano
Department Name
Ospedale San Luca, Dipartimento di Cardiologia
Principal Investigator Name
Claudia Baratto
Principal Investigator Email
c.baratto@auxologico.it
Contact Person Name
Claudia Baratto
Contact Person Email
c.baratto@auxologico.it
Site Name
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Department Name
UOSD Medicina Interna Angiologia e Malattie Aterosclerotiche
Principal Investigator Name
Egidio Imbalzano
Principal Investigator Email
egidio.imbalzano@unime.it
Contact Person Name
Egidio Imbalzano
Contact Person Email
egidio.imbalzano@unime.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Department of Cardiovascular and Thoracic Sciences
Principal Investigator Name
Nadia Aspromonte
Principal Investigator Email
nadia.aspromonte@policlinicogemelli.it
Contact Person Name
Nadia Aspromonte
Site Name
Centro Cardiologico Monzino S.p.A.
Department Name
Centro Cardiologico Monzino IRCCS, Unità Operativa Scompenso e Cardiologia clinica e riabilitativa
Principal Investigator Name
Piergiuseppe Agostoni
Contact Person Name
Piergiuseppe Agostoni

Spain

Earliest CTIS Part Ii Submission Date
09-03-2026
Latest Decision Or Authorization Date
26-03-2026
Processing Time Days
17
Number Of Sites
14
Number Of Participants
33

Sites

Site Name
Hospital Universitario Lucus Augusti
Department Name
Cardiology
Principal Investigator Name
Carlos Gonzalez Juanatey
Principal Investigator Email
carlos.gonzalez.juanatey@sergas.es
Contact Person Name
Carlos Gonzalez Juanatey
Site Name
Hospital Universitari Vall D Hebron
Department Name
Cardiology
Contact Person Name
François ROUBILLE
Contact Person Email
f-roubille@chumontpellier.fr
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Cardiology
Contact Person Name
David STEVANT
Contact Person Email
David.stevant@chunantes.fr
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Cardiology
Principal Investigator Name
Jose Manuel Garcia Pinilla
Principal Investigator Email
eecccardiohuvv@gmail.com
Contact Person Name
Jose Manuel Garcia Pinilla
Contact Person Email
eecccardiohuvv@gmail.com
Site Name
Hospital Blua Sanitas Valdebebas
Department Name
Cardiology
Principal Investigator Name
Santiago de Dios Pérez
Principal Investigator Email
drdedios@gmail.com
Contact Person Name
Santiago de Dios Pérez
Contact Person Email
drdedios@gmail.com
Site Name
Hospital Costa Del Sol
Department Name
Cardiology
Principal Investigator Name
Rafael Bravo Marqués
Principal Investigator Email
rafabravomarques@gmail.com
Contact Person Name
Rafael Bravo Marqués
Contact Person Email
rafabravomarques@gmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Cardiology
Principal Investigator Name
Eduard Sole Gonzalez
Principal Investigator Email
edsole@clinic.cat
Contact Person Name
Eduard Sole Gonzalez
Contact Person Email
edsole@clinic.cat
Site Name
Consorci Mar Parc De Salut De Barcelona
Department Name
Cardiology
Principal Investigator Name
Sonia Ruiz Bustillo
Principal Investigator Email
sruiz@hmar.cat
Contact Person Name
Sonia Ruiz Bustillo
Contact Person Email
sruiz@hmar.cat
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Cardiology
Principal Investigator Name
Julio Eduardo Nuñez Villota
Principal Investigator Email
yulnunez@gmail.com
Contact Person Name
Julio Eduardo Nuñez Villota
Contact Person Email
yulnunez@gmail.com
Site Name
Hospital Universitario La Paz
Department Name
Cardiology
Principal Investigator Name
Maria Isabel Antorrena Miranda
Principal Investigator Email
ensayosclinicoscardio@gmail.com
Contact Person Name
Maria Isabel Antorrena Miranda
Site Name
Hospital Universitario De Toledo
Department Name
Cardiology
Principal Investigator Name
María Lázaro Salvador
Principal Investigator Email
maria.lasal@gmail.com
Contact Person Name
María Lázaro Salvador
Contact Person Email
maria.lasal@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Cardiology
Principal Investigator Name
Alejandro Recio Mayoral
Principal Investigator Email
jandrorm@hotmail.com
Contact Person Name
Alejandro Recio Mayoral
Contact Person Email
jandrorm@hotmail.com
Site Name
Clinica Universidad De Navarra
Department Name
Cardiology
Principal Investigator Name
Juan Jose Gavira Gomez
Principal Investigator Email
jjgavira@unav.es
Contact Person Name
Juan Jose Gavira Gomez
Contact Person Email
jjgavira@unav.es
Site Name
Hospital Universitario De Salamanca
Department Name
Cardiology
Principal Investigator Name
David Gonzalez Calle
Principal Investigator Email
davidgcalle@saludcastillayleon.es
Contact Person Name
David Gonzalez Calle

Poland

Earliest CTIS Part Ii Submission Date
17-03-2026
Latest Decision Or Authorization Date
27-03-2026
Processing Time Days
10
Number Of Sites
3
Number Of Participants
35

Sites

Site Name
Uniwersytecki Szpital Kliniczny W Poznaniu
Department Name
Uniwersytecki Ośrodek Wczesnych Faz
Principal Investigator Name
Ewa StraburzyńskaMigaj
Principal Investigator Email
dlipski@ump.edu.pl
Contact Person Name
Ewa StraburzyńskaMigaj
Contact Person Email
dlipski@ump.edu.pl
Site Name
4 Wojskowy Szpital Kliniczny Z Polikliniką Samodzielny Publiczny Zakład Opieki Zdrowotnej We Wrocławiu
Department Name
Ośrodek Chorób Serca, Klinika Kardiologii z Oddziałami
Principal Investigator Name
Bartosz Krakowiak
Principal Investigator Email
bkrakowiak@4wsk.pl
Contact Person Name
Bartosz Krakowiak
Contact Person Email
bkrakowiak@4wsk.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Instytut Chorób Serca
Principal Investigator Name
Piotr Gajewski
Principal Investigator Email
badaniakliniczne@usk.wroc.pl
Contact Person Name
Piotr Gajewski
Contact Person Email
badaniakliniczne@usk.wroc.pl

Bulgaria

Earliest CTIS Part Ii Submission Date
20-03-2026
Latest Decision Or Authorization Date
02-04-2026
Processing Time Days
13
Number Of Sites
5
Number Of Participants
22

Sites

Site Name
University Hospital Lozenetz
Department Name
Cardiology
Principal Investigator Name
Rayna Tasheva
Principal Investigator Email
dr_tasheva@abv.bg
Contact Person Name
Rayna Tasheva
Contact Person Email
dr_tasheva@abv.bg
Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Cardiology
Principal Investigator Name
Konstantin Gospodinov
Principal Investigator Email
drkdg@abv.bg
Contact Person Name
Konstantin Gospodinov
Contact Person Email
drkdg@abv.bg
Site Name
Medical Center Medconsult Burgas EOOD
Department Name
Cardiology
Principal Investigator Name
Iana Simova
Principal Investigator Email
ianasimova@gmail.com
Contact Person Name
Iana Simova
Contact Person Email
ianasimova@gmail.com
Site Name
Alexandrovska University Hospital
Department Name
Clinic of Cardiology
Principal Investigator Name
Kiril Karamfiloff
Principal Investigator Email
dr.kiril.karamfilov@gmail.com
Contact Person Name
Kiril Karamfiloff
Contact Person Email
dr.kiril.karamfilov@gmail.com
Site Name
University Hospital St. Anna
Department Name
Cardiology
Principal Investigator Name
Dimitar Raev
Principal Investigator Email
draevbg56@yahoo.com
Contact Person Name
Dimitar Raev
Contact Person Email
draevbg56@yahoo.com

Czechia

Earliest CTIS Part Ii Submission Date
05-03-2026
Latest Decision Or Authorization Date
12-05-2026
Processing Time Days
68
Number Of Sites
3
Number Of Participants
31

Sites

Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Kardiologická klinika
Principal Investigator Name
Petr Toušek
Principal Investigator Email
Petr.tousek@fnkv.cz
Contact Person Name
Petr Toušek
Contact Person Email
Petr.tousek@fnkv.cz
Site Name
Mestska Nemocnice Ostrava Prispevkova Organizace
Department Name
Kardiologie
Principal Investigator Name
Marcel Heczko
Principal Investigator Email
marcel.heczko@mnof.cz
Contact Person Name
Marcel Heczko
Contact Person Email
marcel.heczko@mnof.cz
Site Name
Fakultni Nemocnice Motol A Homolka
Department Name
Kardiologická klinika 2. LF UK a FN Motol
Principal Investigator Name
Václav Durdil
Principal Investigator Email
vaclav.durdil@fnmotol.cz
Contact Person Name
Václav Durdil
Contact Person Email
vaclav.durdil@fnmotol.cz

Sponsor

Primary sponsor

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

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
CRO

Third parties

  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"","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":"Medpace Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"CRO","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Allucent (US) LLC","duties_or_roles":"Ambulatory ECG monitors/arrhythmia monitoring","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Levosimendan
Active Substance
LEVOSIMENDAN
Modality
Small molecule
Routes Of Administration
Oral
Route
Oral
Investigational Product Name
The levosimendan placebo drug product (immediate-release oral)
Modality
Other
Routes Of Administration
Oral
Route
Oral

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