Clinical trial • Phase II/III • Cardiology
DANICAMTIV for Dilated cardiomyopathy | Genetic dilated cardiomyopathy | Familial dilated cardiomyopathy
Phase II/III trial of DANICAMTIV for Dilated cardiomyopathy | Genetic dilated cardiomyopathy | Familial dilated cardiomyopathy.
Overview
- Trial Therapeutic Area
- Cardiology
- Trial Disease
- Dilated cardiomyopathy | Genetic dilated cardiomyopathy | Familial dilated cardiomyopathy
- Trial Stage
- Phase II/III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 30-09-2025
- First CTIS Authorization Date
- 30-01-2026
Trial design
Randomised, placebo tablets containing the same excipients as danicamtiv tablets (placebo arm). dose and schedule not specified in the provided documents.-controlled, adaptive Phase II/III trial in Italy, Netherlands, Hungary and others.
- Randomised
- Yes
- Comparator
- Placebo tablets containing the same excipients as Danicamtiv tablets (placebo arm). Dose and schedule not specified in the provided documents.
- Adaptive
- True, study described as adaptive (Phase 2b/3). Specific adaptive elements (interim analyses, stopping rules, or detailed adaptation rules) are not provided in the available materials.
- Target Sample Size
- 92
- Trial Duration For Participant
- 182
Eligibility
Recruits 92 Vulnerable population selected (isVulnerablePopulationSelected = true). All participants must be adults (≥18 years). Written informed consent must be provided by the participant according to local and institutional guidelines before the first study-specific procedure. No assent or parental consent provisions are described in the provided material..
- Pregnancy Exclusion
- 30. Is pregnant or breastfeeding.
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). All participants must be adults (≥18 years). Written informed consent must be provided by the participant according to local and institutional guidelines before the first study-specific procedure. No assent or parental consent provisions are described in the provided material.
Inclusion criteria
- {"criterion_text":"- 1. Is an adult ≥18 years of age at the Screening visit.\n- 10. Is able to understand and comply with the study procedures, understand the risks involved in the study, and provide written informed consent according to local and institutional guidelines before the first study-specific procedure.\n- 2. Has a diagnosis of dilated cardiomyopathy (DCM) due to probable disease-causing variants of myosin heavy chain 7(MYH7), titin (TTN), or other identified genetic DCM variants, or with familial DCM.\n- 3. Has New York Heart Association (NYHA) Class II-IV at Screening with stable symptoms for ≥1 month.\n- 4. Has chronic DCM, defined as not due to acute or possibly reversible conditions (e.g., hyper/hypothyroidism, infectious cause, tachyarrhythmia, iron overload), according to the Investigator.\n- 5. Has DCM not attributed to substance abuse, amyloidosis, sarcoidosis, or any other secondary form of cardiomyopathy per the Investigator.\n- 6. Has sinus rhythm, stable atrial or ventricular pacing or paroxysmal atrial fibrillation that is adequately rate-controlled when in the arrhythmia, to allow assessments by TTE.\n- 7. Can perform an upright cardiopulmonary exercise testing (CPET) with a peak oxygen consumption (pVO2) of 80% or less of predicted for a healthy individual and RER of ≥1.05 on the Screening CPET, as confirmed by the CPET Core Laboratory.\n- 8. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. All participants, if sexually active, must use 1 of the highly effective birth control methods listed in the protocol from the Screening visit through 3 months after the last dose of IMP."}
Exclusion criteria
- {"criterion_text":"- 1. Has heart failure with reduced ejection (HFrEF) caused primarily by ischemic heart disease, chronic valvulopathy, or another condition, as determined by the Investigator.\n- 25. Thyroid-stimulating hormone >1.5 × ULN at Screening.\n- 26. Serum creatine kinase >3 × ULN at Screening.\n- 10. History of malignancy of any type within 5 years prior to Screening, except for in situ cervical cancer, non-melanomatous skin cancers, ductal carcinoma in situ, and nonmetastatic prostate cancer, which resolved one year prior to screening.\n- 27. Positive for hepatitis B surface antigen or hepatitis C virus (HCV) antibody (anti-HCV) plus HCV-RNA. Participants who are anti-HCV positive but HCV-RNA negative (secondary to treatment or natural viral clearance) are eligible with at least a 1-year period since documented date of RNA polymerase chain reaction negative confirmation following conclusion of treatment.\n- 28. Has hypersensitivity to danicamtiv or any of the components of the danicamtiv formulation.\n- 29. Has life expectancy <6 months.\n- 3. Had coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG]) within prior 90 days.\n- 30. Is pregnant or breastfeeding.\n- 31. Is employed by or is a first-degree relative of someone employed by the Sponsor, the Investigator, or his/her staff or family.\n- 4. Recent (<90 days) hospitalization for heart failure (HF) or use of intravenous (IV) diuretic.\n- 18. Has planned cardiac resynchronization therapy (CRT) or major surgery planned in the next 6 months.\n- 6. Known aortic stenosis of moderate or greater severity, at the discretion of the Investigator.\n- 7. Presence of disqualifying cardiac rhythms that might interfere with reliable echocardiographic measurements of LV function, as determined by the Investigator including: (a) inadequately rate-controlled atrial fibrillation, (b) ectopic beats (atrial, junctional or ventricular) of sufficient frequency (e.g. > 10% of total beats) that the participant's cardiac rhythm is irregular potentially interfering with reliable echocardiographic measurements of LV function.\n- 11. Severe renal insufficiency (defined at the time of Screening as current estimated glomerular filtration rate [eGFR] <15 mL/min/1.73m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.\n- 8. Unstable or untreated severe ventricular arrythmia (eg, ventricular tachycardia or ventricular fibrillation).\n- 9. Has active infection indicated clinically as determined by the Investigator. In the case of SARS-CoV-2 (COVID-19) infection within 4 weeks prior to and during Screening, symptoms must have completely resolved and based on Investigator assessment in consultation with the Medical Monitor, there are no sequelae that would place the participant at a higher risk if receiving investigational treatment. The methods to assess SARS-CoV-2 (COVID-19) infection include polymerase chain reaction (PCR), antigen test and serology tests.\n- 5. Other recent (<90 days) cardiovascular event (e.g., cerebrovascular accident).\n- 12. History or evidence of any other clinically significant disorder, condition, or disease (including substance abuse) that, in the opinion of the Investigator or Sponsor, would pose a risk to participant safety or interfere with the study evaluation, procedures, completion, or lead to premature withdrawal from the study.\n- 13. Dependent on continuous oxygen supplementation, severe chronic obstructive pulmonary disease (COPD) or restrictive lung disease that may impact CPET performance.\n- 14. Significant hematologic, orthopedic, neuromuscular, or rheumatologic conditions limiting exercise capacity.\n- 15. History of heart transplantation or anticipated heart transplantation in the next 6 months.\n- 19. Has a ventricular assist device or anticipated ventricular assist device placement planned in the next 6 months.\n- 16. Any condition deemed by the Investigator to pose an unacceptable risk for CPET or interfere with study assessments.\n- 17. Receives chronic IV inotropic therapy.\n- 2. Recent (<90 days) acute coronary syndrome or hemodynamically significant epicardial coronary disease, at the discretion of the Investigator.\n- 20. Participated in a clinical trial in which the participant received any investigational drug (or is currently using an investigational device) within 30 days prior to Screening, or less than 5 times the respective elimination half-life (whichever is longer).\n- 21. Serum potassium <3.5 or >5.5 mEq/L at the Screening Visit.\n- 22. Any persistent (2 or more) out-of-range safety laboratory parameters (including chemistry, hematology), considered by the Investigator and Medical Monitor to be clinically significant.\n- 23. Hemoglobin <10g/L at Screening, confirmed on repeat testing if initial result is borderline or deemed not clinically significant by the Investigator.\n- 24. Has active liver disease, defined as any known current infectious, neoplastic, or metabolic, pathology of the liver; unexplained elevations in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 × upper limit of normal (ULN); or total bilirubin (TBL) >2 × ULN at Screening."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from Baseline (Day 1) to Week 26 in left atrial function index (LAFI) in Cohort 1.\n- Change from Baseline to Week 26 in peak oxygen consumption (pVO2) in Cohort 1.","definition_or_measurement_approach":"LAFI: measured by transthoracic echocardiogram (TTE) from Baseline (Day 1) to Week 26 in Cohort 1 as described in the trial main objective.\npVO2: measured by upright cardiopulmonary exercise testing (CPET) (peak oxygen consumption) from Baseline to Week 26 in Cohort 1, with CPET results confirmed by the CPET Core Laboratory."}
Recruitment
- Digital Remote Recruitment
- True, recruitment materials include website packages/website content and online participant materials (country-specific website material indicated in K2 recruitment documents).
- Planned Sample Size
- 92
- Recruitment Window Months
- 19
- Consent Approach
- Written informed consent is required from each participant according to local and institutional guidelines prior to any study-specific procedure (inclusion criterion: 'provide written informed consent according to local and institutional guidelines before the first study-specific procedure'). Participants are adults (≥18), so consent is provided by the participant. Multiple language ICFs and subject information documents are provided (examples include English, French, Italian, Polish, Swedish, Spanish, Dutch and country-specific versions); additional ICFs such as Pregnancy ICF, Genetic ICF and Privacy ICF are listed in the submitted documents.
Methods
- Country-specific recruitment arrangements documents (K1_Recruitment arrangements) submitted for each participating country (examples: Italy, Netherlands, Hungary, France, Poland, Belgium, Sweden, Spain, Denmark).
- Participant flyers (K2_Recruitment material_Flyer / ParticipantFlyer) for patient-facing print distribution (available in multiple country-specific versions).
- Website/online recruitment materials (K2_Recruitment material_Website Package / Website content / Participant Website) for digital outreach and information.
- GP letter (document: Other subject information material_GP Letter_Kardigan) identified as part of subject-facing materials.
Geography
- Total Number Of Sites
- 36
- Total Number Of Participants
- 222
Italy
- Earliest CTIS Part Ii Submission Date
- 20-01-2026
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 13
- Number Of Sites
- 6
- Number Of Participants
- 36
Sites
- Site Name
- ASST Grande Ospedale Metropolitano Niguarda
- Department Name
- Cardiology 2
- Principal Investigator Name
- Enrico Ammirati
- Principal Investigator Email
- enrico.ammirati@ospedaleniguarda.it
- Contact Person Name
- Enrico Ammirati
- Contact Person Email
- enrico.ammirati@ospedaleniguarda.it
- Site Name
- Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
- Department Name
- University Cardiology Unit, Interdisciplinary Department of Medicine
- Principal Investigator Name
- Andrea Igoren Guaricci
- Principal Investigator Email
- andreaigoren.guaricci@uniba.it
- Contact Person Name
- Andrea Igoren Guaricci
- Contact Person Email
- andreaigoren.guaricci@uniba.it
- Site Name
- Azienda Ospedaliero Universitaria Careggi
- Department Name
- Experimental and Clinical Medicine
- Principal Investigator Name
- Iacopo Olivotto
- Principal Investigator Email
- iacopo.olivotto@unifi.it
- Contact Person Name
- Iacopo Olivotto
- Contact Person Email
- iacopo.olivotto@unifi.it
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Department of Cardiovascular Medicine
- 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
- Centro Cardiologico Monzino S.p.A.
- Department Name
- Heart Failure and Clinical Cardiology and Rehabilitation Department
- Principal Investigator Name
- Piergiuseppe Agostoni
- Principal Investigator Email
- piergiuseppe.agostoni@cardiologicomonzino.it
- Contact Person Name
- Piergiuseppe Agostoni
- Contact Person Email
- piergiuseppe.agostoni@cardiologicomonzino.it
- Site Name
- Azienda Sanitaria Universitaria Giuliano Isontina
- Department Name
- Cardiothoracovascular
- Principal Investigator Name
- Marco Merlo
- Principal Investigator Email
- marco.merlo@asugi.sanita.fvg.it
- Contact Person Name
- Marco Merlo
- Contact Person Email
- marco.merlo@asugi.sanita.fvg.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 21-01-2026
- Latest Decision Or Authorization Date
- 30-04-2026
- Processing Time Days
- 99
- Number Of Sites
- 3
- Number Of Participants
- 19
Sites
- Site Name
- Amsterdam UMC Stichting
- Department Name
- cardiology
- Principal Investigator Name
- Ahmad Amin
- Principal Investigator Email
- a.s.amin@amsterdamumc.nl
- Contact Person Name
- Ahmad Amin
- Contact Person Email
- a.s.amin@amsterdamumc.nl
- Site Name
- Academisch Ziekenhuis Maastricht
- Department Name
- Cardiology
- Principal Investigator Name
- Stephane Heymans
- Principal Investigator Email
- s.heymans@maastrichtuniversity.nl
- Contact Person Name
- Stephane Heymans
- Contact Person Email
- s.heymans@maastrichtuniversity.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Department of Cardiology
- Principal Investigator Name
- Michelle Michels
- Principal Investigator Email
- m.michels@erasmusmc.nl
- Contact Person Name
- Michelle Michels
- Contact Person Email
- m.michels@erasmusmc.nl
Hungary
- Earliest CTIS Part Ii Submission Date
- 17-11-2025
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 163
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Semmelweis University
- Department Name
- Városmajori Szív és Érgyógyászati Klinika
- Principal Investigator Name
- Béla Merkely
- Principal Investigator Email
- merkely.study@gmail.com
- Contact Person Name
- Béla Merkely
- Contact Person Email
- merkely.study@gmail.com
- Site Name
- University Of Szeged
- Department Name
- Belgyógyászati Klinika, Kardiológiai Centrum
- Principal Investigator Name
- Róbert Sepp
- Principal Investigator Email
- sepprobert@med.u-szeged.hu
- Contact Person Name
- Róbert Sepp
- Contact Person Email
- sepprobert@med.u-szeged.hu
France
- Earliest CTIS Part Ii Submission Date
- 05-12-2025
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 159
- Number Of Sites
- 2
- Number Of Participants
- 29
Sites
- Site Name
- Hopitaux Universitaires Pitie Salpetriere
- Department Name
- Service de Cardiologie
- Principal Investigator Name
- Philippe Charron
- Principal Investigator Email
- philippe.charron@aphp.fr
- Contact Person Name
- Philippe Charron
- Contact Person Email
- philippe.charron@aphp.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- INSERM CIC1418
- Principal Investigator Name
- Karim Wahbi
- Principal Investigator Email
- karim.wahbi@aphp.fr
- Contact Person Name
- Karim Wahbi
- Contact Person Email
- karim.wahbi@aphp.fr
Poland
- Earliest CTIS Part Ii Submission Date
- 16-12-2025
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 133
- Number Of Sites
- 4
- Number Of Participants
- 15
Sites
- Site Name
- 4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
- Department Name
- Klinika Kardiologii
- Principal Investigator Name
- Bartosz Krakowiak
- Principal Investigator Email
- szpital@4wsk.pl
- Contact Person Name
- Bartosz Krakowiak
- Contact Person Email
- szpital@4wsk.pl
- Site Name
- Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
- Department Name
- Oddział Kliniczny Chorób Serca i Naczyń
- Principal Investigator Name
- Paweł Rubiś
- Principal Investigator Email
- pawelrub@poczta.onet.pl
- Contact Person Name
- Paweł Rubiś
- Contact Person Email
- pawelrub@poczta.onet.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
- Department Name
- 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
- Site Name
- Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy
- Department Name
- Klinika Niewydolności Serca i Transplantologii i Mechanicznego Wspomagania Serca
- Principal Investigator Name
- Przemyslaw Leszek
- Principal Investigator Email
- pleszek@ikard.pl
- Contact Person Name
- Przemyslaw Leszek
- Contact Person Email
- pleszek@ikard.pl
Belgium
- Earliest CTIS Part Ii Submission Date
- 19-01-2026
- Latest Decision Or Authorization Date
- 28-04-2026
- Processing Time Days
- 99
- Number Of Sites
- 5
- Number Of Participants
- 33
Sites
- Site Name
- Azorg
- Department Name
- Cardiology
- Principal Investigator Name
- Marc Vanderheyden
- Principal Investigator Email
- marc.vanderheyden@azorg.be
- Contact Person Name
- Marc Vanderheyden
- Contact Person Email
- marc.vanderheyden@azorg.be
- Site Name
- UZ Leuven
- Department Name
- Cardiology
- Principal Investigator Name
- Tomas Robyns
- Principal Investigator Email
- tomas.robyns@uzleuven.be
- Contact Person Name
- Tomas Robyns
- Contact Person Email
- tomas.robyns@uzleuven.be
- Site Name
- Hopital Erasme
- Department Name
- Cardiology
- Principal Investigator Name
- Antoine Bondue
- Principal Investigator Email
- antoine.bondue@hubruxelles.be
- Contact Person Name
- Antoine Bondue
- Contact Person Email
- antoine.bondue@hubruxelles.be
- Site Name
- Universitair Ziekenhuis Antwerpen
- Department Name
- Cardiology
- Principal Investigator Name
- Emeline Van Craenenbroeck
- Principal Investigator Email
- emeline.vancraenenbroeck@uantwerpen.be
- Contact Person Name
- Emeline Van Craenenbroeck
- Contact Person Email
- emeline.vancraenenbroeck@uantwerpen.be
- Site Name
- Jessa Ziekenhuis
- Department Name
- Cardiology
- Principal Investigator Name
- Pieter Koopman
- Principal Investigator Email
- Pieter.Koopman@jessazh.be
- Contact Person Name
- Pieter Koopman
- Contact Person Email
- Pieter.Koopman@jessazh.be
Sweden
- Earliest CTIS Part Ii Submission Date
- 02-01-2026
- Latest Decision Or Authorization Date
- 04-05-2026
- Processing Time Days
- 122
- Number Of Sites
- 2
- Number Of Participants
- 18
Sites
- Site Name
- Soedersjukhuset AB
- Department Name
- VO Kardiologi
- Principal Investigator Name
- Gianluigi Savarese
- Principal Investigator Email
- gianluigi.savarese@ki.se
- Contact Person Name
- Gianluigi Savarese
- Contact Person Email
- gianluigi.savarese@ki.se
- Site Name
- Danderyds Sjukhus AB
- Department Name
- VO Hjärt-Fysiologi
- Principal Investigator Name
- Krister Lindmark
- Principal Investigator Email
- krister.lindmark@regionstockholm.se
- Contact Person Name
- Krister Lindmark
- Contact Person Email
- krister.lindmark@regionstockholm.se
Spain
- Earliest CTIS Part Ii Submission Date
- 13-01-2026
- Latest Decision Or Authorization Date
- 29-04-2026
- Processing Time Days
- 106
- Number Of Sites
- 9
- Number Of Participants
- 48
Sites
- Site Name
- Area Sanitaria Da Coruna E Cee
- Department Name
- Cardiology
- Principal Investigator Name
- Roberto Barriales Villa
- Principal Investigator Email
- Roberto.Barriales.Villa@sergas.es
- Contact Person Name
- Roberto Barriales Villa
- Contact Person Email
- Roberto.Barriales.Villa@sergas.es
- Site Name
- University Hospital Virgen Del Rocio S.L.
- Department Name
- Cardiology
- Principal Investigator Name
- Maria Luisa Peña Peña
- Principal Investigator Email
- cardiopatiasfamiliares.hvr.sspa@juntadeandalucia.es
- Contact Person Name
- Maria Luisa Peña Peña
- Contact Person Email
- cardiopatiasfamiliares.hvr.sspa@juntadeandalucia.es
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Cardiology
- Principal Investigator Name
- Pablo Garcia Pavia
- Principal Investigator Email
- cardiopatiasfamiliares.hpth@salud.madrid.org
- Contact Person Name
- Pablo Garcia Pavia
- Contact Person Email
- cardiopatiasfamiliares.hpth@salud.madrid.org
- Site Name
- Hospital Son Llatzer
- Department Name
- Cardiology
- Principal Investigator Name
- Jorge Álvarez Rubio
- Principal Investigator Email
- jalvarezr@hsll.es
- Contact Person Name
- Jorge Álvarez Rubio
- Contact Person Email
- jalvarezr@hsll.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Cardiology
- Principal Investigator Name
- Javier Limeres Freire
- Principal Investigator Email
- javier.limeres@vallhebron.cat
- Contact Person Name
- Javier Limeres Freire
- Contact Person Email
- javier.limeres@vallhebron.cat
- Site Name
- Bellvitge University Hospital
- Department Name
- Cardiology
- Principal Investigator Name
- Fernando de Frutos Seminario
- Principal Investigator Email
- fdefrutos@bellvitgehospital.cat
- Contact Person Name
- Fernando de Frutos Seminario
- Contact Person Email
- fdefrutos@bellvitgehospital.cat
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Cardiology
- Principal Investigator Name
- Juan Ramon Gimeno Blanes
- Principal Investigator Email
- jgimeno@secardiologia.es
- Contact Person Name
- Juan Ramon Gimeno Blanes
- Contact Person Email
- jgimeno@secardiologia.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Cardiology
- Principal Investigator Name
- Ainhoa Robles Mezcua
- Principal Investigator Email
- ainhoa.mezcua@gmail.com
- Contact Person Name
- Ainhoa Robles Mezcua
- Contact Person Email
- ainhoa.mezcua@gmail.com
- Site Name
- Hospital (additional Spanish site listed)
- Department Name
- Cardiology
Denmark
- Earliest CTIS Part Ii Submission Date
- 08-01-2026
- Latest Decision Or Authorization Date
- 24-04-2026
- Processing Time Days
- 106
- Number Of Sites
- 3
- Number Of Participants
- 14
Sites
- Site Name
- Region Midtjylland
- Department Name
- Department of Cardiology
- Principal Investigator Name
- Torsten Rasmussen
- Principal Investigator Email
- torasm@rm.dk
- Contact Person Name
- Torsten Rasmussen
- Contact Person Email
- torasm@rm.dk
- Site Name
- Rigshospitalet
- Department Name
- Department of Cardiology
- Principal Investigator Name
- Anna Axelsson Raja
- Principal Investigator Email
- anna.axelsson.raja@regionh.dk
- Contact Person Name
- Anna Axelsson Raja
- Contact Person Email
- anna.axelsson.raja@regionh.dk
- Site Name
- Odense University Hospital
- Department Name
- Department of Cardiology
- Principal Investigator Name
- Thomas Hey
- Principal Investigator Email
- thomas.morris.hey@rsyd.dk
- Contact Person Name
- Thomas Hey
- Contact Person Email
- thomas.morris.hey@rsyd.dk
Sponsor
Primary sponsor
- Full Name
- Kardigan Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Medpace Finland Oy
- Name
- Clinchoice Inc.
- Name
- Veranex Inc.
- Name
- Medidata Solutions Inc.
- Name
- Suvoda LLC
Third parties
- {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Baim Institute For Clinical Research Inc.","duties_or_roles":"ARO; Adjudication; ECG testing","organisation_type":"Educational Institution"}
- {"country":"United States","full_name":"The Brigham And Women’s Hospital Inc.","duties_or_roles":"Imaging - ECHO","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Prolaio Inc.","duties_or_roles":"ePROs; Wearable Devices","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Mural Health Technologies Inc.","duties_or_roles":"Patient Travel and Reimbursement Support","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Massachusetts General Hospital","duties_or_roles":"Imaging - CPET","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"United States","full_name":"Veranex Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Thermo Fisher Scientific Inc.","duties_or_roles":"","organisation_type":"Industry"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Clinchoice Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Ambry Genetics Corp.","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
Investigational products
- Investigational Product Name
- Danicamtiv
- Active Substance
- DANICAMTIV
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
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