A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejection Fraction (Cycle-1-REF)
NCT ID: NCT06215911
Last Updated: 2025-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
557 participants
INTERVENTIONAL
2024-02-13
2025-10-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tovinontrine (CRD-750) - low dose
Tovinontrine (CRD-750)
Tablets administered orally
Tovinontrine (CRD-750) - medium dose
Tovinontrine (CRD-750)
Tablets administered orally
Tovinontrine (CRD-750) - high dose
Tovinontrine (CRD-750)
Tablets administered orally
Placebo
Placebo
Tablets administered orally
Interventions
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Tovinontrine (CRD-750)
Tablets administered orally
Placebo
Tablets administered orally
Eligibility Criteria
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Inclusion Criteria
* Has evidence in the medical history supporting a diagnosis of clinical HF syndrome, NYHA functional class II to III, with the duration of at least 6 months prior to the time of Screening. The HF syndrome is defined by documentation of 1 or more of the following:
* At least 1 of the typical symptoms due to HF such as dyspnea and/or fatigue limiting exercise capacity;
* At least 1 of the typical signs of HF such as peripheral edema, elevated jugular venous pressure, pulmonary crackles; or
* Hospitalization, emergency department visit, or outpatient visit for HF requiring intravenous (IV) or subcutaneous (SQ) diuresis within the past 12 months.
* Has ejection fraction (EF) ≤ 40% by transthoracic echocardiogram (TTE) performed and interpreted locally at the time of Screening;
* Has NT-proBNP level ≥ 600 pg/mL at the time of Screening. Patients with atrial fibrillation or flutter at the time of Screening are required to have an NT-proBNP level of ≥ 1000 pg/mL at the time of Screening;
* Is on stable optimized doses of guideline-directed HF therapy, per Investigator's clinical judgement, for a minimum of 4 weeks prior to the time of Screening and during Screening, with no planned changes after randomization.
* Has had no addition of new guideline-directed HF therapy within the 3 months prior to the time of Screening or during the Screening Period;
Exclusion Criteria
* Has evidence of recent HF exacerbation defined by hospitalization or requirement for IV or SQ diuretics within 60 days of the time of Screening or during the Screening Period;
* Has a requirement for routine, scheduled outpatient IV infusions for HF (ie, inotropes, vasodilators, or diuretics) or routinely scheduled ultrafiltration;
* Has elective interventions (eg, percutaneous coronary intervention, device implantations, percutaneous structural heart disease interventions, cardiac and non-cardiac surgery) planned to occur during involvement in this study;
* Has acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, or carotid angioplasty within 60 days of the time of Screening or during the Screening Period;
* Has had a prior or planned orthotopic heart transplantation;
* Has presence of or plan for mechanical circulatory support;
18 Years
ALL
No
Sponsors
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Cardurion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gail Berman
Role: STUDY_DIRECTOR
Senior VP Head, Clinical Development Cardurion
Locations
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Cardurion Investigative Site
Birmingham, Alabama, United States
Cardurion Investigative Site
Little Rock, Arkansas, United States
Cardurion Investigative Site
Beverly Hills, California, United States
Cardurion Investigative Site
Orange, California, United States
Cardurion Investigative Site
Torrance, California, United States
Cardurion Investigative Site
Van Nuys, California, United States
Cardurion Investigative Site
Jacksonville, Florida, United States
Cardurion Investigative Site
Miami, Florida, United States
Cardurion Investigative Site
Hazel Crest, Illinois, United States
Cardurion Investigative Site
Peoria, Illinois, United States
Cardurion Investigative Site
Alexandria, Louisiana, United States
Cardurion Investigative Site
Covington, Louisiana, United States
Cardurion Investigative Site
Baltimore, Maryland, United States
Cardurion Investigative Site
St Louis, Missouri, United States
Cardurion Investigative Site
Omaha, Nebraska, United States
Cardurion Investigative Site
Buffalo, New York, United States
Cardurion Investigative Site
New York, New York, United States
Cardurion Investigative Site
Cleveland, Ohio, United States
Cardurion Investigative Site
Oklahoma City, Oklahoma, United States
Cardurion Investigative Site
Rapid City, South Dakota, United States
Cardurion Investigative Site
Nashville, Tennessee, United States
Cardurion Investigative Site
Dallas, Texas, United States
Cardurion Investigative Site
McKinney, Texas, United States
Cardurion Investigative Site
Burlington, Vermont, United States
Cardurion Investigative Site
Seattle, Washington, United States
Cardurion Investigative Site
Madison, Wisconsin, United States
Cardurion Investigative Site
Southport, Queensland, Australia
Cardurion Investigative Site
Chermside, , Australia
Cardurion Investigative Site
Perth, , Australia
Cardurion Investigational Site
Bruges, , Belgium
Cardurion Investigative Site
Brussels, , Belgium
Cardurion Investigative Site
Brussels, , Belgium
Cardurion Investigative Site
Genk, , Belgium
Cardurion Investigative Site
Ghent, , Belgium
Cardurion Investigative Site
Hasselt, , Belgium
Cardurion Investigative Site
Kortrijk, , Belgium
Cardurion Investigative Site
Sint-Niklaas, , Belgium
Cardurion Investigative Site
Burgas, , Bulgaria
Cardurion Investigative Site
Gabrovo, , Bulgaria
Cardurion Investigative Site
Pazardzhik, , Bulgaria
Cardurion Investigative Site
Plovdiv, , Bulgaria
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Plovdiv, , Bulgaria
Cardurion Investigative Site
Rousse, , Bulgaria
Cardurion Investigative Site
Sofia, , Bulgaria
Cardurion Investigative Site 2
Sofia, , Bulgaria
Cardurion Investigative Site
Sofia, , Bulgaria
Cardurion Investigative Site
Stara Zagora, , Bulgaria
Cardurion Investigative Site
Veliko Tarnovo, , Bulgaria
Cardurion Investigative Site
Cambridge, Ontario, Canada
Cardurion Investigative Site
Hamilton, Ontario, Canada
Cardurion Investigative Site
Chicoutimi, Quebec, Canada
Cardurion Investigative Site
Montreal, Quebec, Canada
Cardurion Investigative Site
Sherbrooke, , Canada
Cardurion Investigative Site
Trois-Rivières, , Canada
Cardurion Investigative Site
Hradec Králové, , Czechia
Cardurion Investigative Site
Hradec Králové, , Czechia
Cardurion Investigative Site
Prague, , Czechia
Cardurion Investigative Site
Tbilisi, , Georgia
Cardurion Investigative Site
Tbilisi, , Georgia
Cardurion Investigative Site
Tbilisi, , Georgia
Cardurion Investigative Site 2
Tbilisi, , Georgia
Cardurion Investigative Site
Tbilisi, , Georgia
Cardurion Investigative Site
Tbilisi, , Georgia
Cardurion Investigative Site
Tbilisi, , Georgia
Cardurion Investigative Site
Berlin, Brandenburg, Germany
Cardurion Investigative Site
Elsterwerda, Brandenburg, Germany
Cardurion Investigative Site
Papenburg, Lower Saxony, Germany
Cardurion Investigative Site
Dresden, , Germany
Cardurion Investigative Site
Magdeburg, , Germany
Cardurion Investigative Site
Balatonfüred, , Hungary
Cardurion Investigative Site
Budapest, , Hungary
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Budapest, , Hungary
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Gyöngyös, , Hungary
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Hatvan, , Hungary
Cardurion Investigative Site
Kaposvár, , Hungary
Cardurion Investigative Site
Orosháza, , Hungary
Cardurion Investigative Site
Zalaegerszeg, , Hungary
Cardurion Investigative Site
Bergamo, , Italy
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Milan, , Italy
Cardurion Investigative Site
Napoli, , Italy
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Rozzano, , Italy
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Riga, , Latvia
Cardurion Investigative Site
Kaunas, , Lithuania
Cardurion Investigative Site
Klaipėda, , Lithuania
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Panevezys, , Lithuania
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Goes, , Netherlands
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Groningen, , Netherlands
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Hardenberg, , Netherlands
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Sneek, , Netherlands
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The Hague, , Netherlands
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Utrecht, , Netherlands
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Veldhoven, , Netherlands
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Zutphen, , Netherlands
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Christchurch, , New Zealand
Cardurion Investigative Site
Dunedin, , New Zealand
Cardurion Investigative Site
Grodzisk Mazowiecki, , Poland
Cardurion Investigative Site
Krakow, , Poland
Cardurion Investigative Site
Lodz, , Poland
Cardurion Investigative Site
Lodz, , Poland
Cardurion Investigative Site
Lodz, , Poland
Cardurion Investigative Site
Lublin, , Poland
Cardurion Investigative Site
Lublin, , Poland
Cardurion Investigative Site
Sopot, , Poland
Cardurion Investigative Site
Szczecin, , Poland
Cardurion Investigative Site
Torun, , Poland
Cardurion Investigative Site
Warsaw, , Poland
Cardurion Investigative Site
Wroclaw, , Poland
Cardurion Investigative Site
Wroclaw, , Poland
Cardurion Investigative Site
Bardejov, , Slovakia
Cardurion Investigative Site
Bratislava, , Slovakia
Cardurion Investigative Site
Handlová, , Slovakia
Cardurion Investigative Site
Košice, , Slovakia
Cardurion Investigative Site
Košice, , Slovakia
Cardurion Investigative Site
Nitra, , Slovakia
Cardurion Investigative Site
Prešov, , Slovakia
Cardurion Investigative Site
Žilina, , Slovakia
Cardurion Investigative Site
El Palmar, Murcia, Spain
Cardurion Investigative Site
Alicante, , Spain
Cardurion Investigative Site
Córdoba, , Spain
Cardurion Investigative Site
Madrid, , Spain
Cardurion Investigative Site
Málaga, , Spain
Cardurion Investigative Site
Santiago de Compostela, , Spain
Cardurion Investigative Site
Seville, , Spain
Cardurion Investigative Site
Valencia, , Spain
Cardurion Investigative Site
Kaohsiung City, , Taiwan
Cardurion Investigative Site
New Taipei City, , Taiwan
Cardurion Investigative Site
Taichung, , Taiwan
Cardurion Investigative Site
Taipei, , Taiwan
Cardurion Investigative Site
Taipei, , Taiwan
Cardurion Investigative Site
Wythenshawe, Manchester, United Kingdom
Cardurion Investigative Site
Bridgend, , United Kingdom
Cardurion Investigative Site
Chichester, , United Kingdom
Cardurion Investigative Site
Dundee, , United Kingdom
Cardurion Investigative Site
Glasgow, , United Kingdom
Cardurion Investigative Site
Harrow, , United Kingdom
Cardurion Investigative Site
Isleworth, , United Kingdom
Cardurion Investigative Site
London, , United Kingdom
Cardurion Investigative Site
London, , United Kingdom
Cardurion Investigative Site
Southampton, , United Kingdom
Countries
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Other Identifiers
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2023-508736-62
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CRD-750-201
Identifier Type: -
Identifier Source: org_study_id
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