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NCT06215911

PHASE2

A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejection Fraction (Cycle-1-REF)

Sponsor: Cardurion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with reduced ejection fraction.

Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Finding Study to Assess the Safety and Effectiveness of Tovinontrine in Patients With Chronic Heart Failure With Reduced Ejection Fraction

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

557

Start Date

2024-02-13

Completion Date

2025-10-10

Last Updated

2026-09-01

Healthy Volunteers

Conditions

Heart Failure Heart Failure With Reduced Ejection Fraction Cardiovascular Diseases Heart Diseases

Interventions

DRUG

Tovinontrine (CRD-750)

Tablets administered orally

DRUG

Placebo

Tablets administered orally

Inclusion Criteria: * Is an adult male or female patient ≥18 years of age * 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 a documented EF \>40% by TTE within 6 months of the time of Screening or during the Screening Period; * 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; Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Locations (139)

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

Cardurion Investigative Site

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

Cardurion Investigative Site

Budapest, Hungary

Cardurion Investigative Site

Gyöngyös, Hungary

Cardurion Investigative Site

Hatvan, Hungary

Cardurion Investigative Site

Kaposvár, Hungary

Cardurion Investigative Site

Orosháza, Hungary

Cardurion Investigative Site

Zalaegerszeg, Hungary

Cardurion Investigative Site

Bergamo, Italy

Cardurion Investigative Site

Milan, Italy

Cardurion Investigative Site

Naples, Italy

Cardurion Investigative Site

Rozzano, Italy

Cardurion Investigative Site

Riga, Latvia

Cardurion Investigative Site

Kaunas, Lithuania

Cardurion Investigative Site

Klaipėda, Lithuania

Cardurion Investigative Site

Panevezys, Lithuania

Cardurion Investigative Site

Goes, Netherlands

Cardurion Investigative Site

Groningen, Netherlands

Cardurion Investigative Site

Hardenberg, Netherlands

Cardurion Investigative Site

Sneek, Netherlands

Cardurion Investigative Site

The Hague, Netherlands

Cardurion Investigative Site

Utrecht, Netherlands

Cardurion Investigative Site

Veldhoven, Netherlands

Cardurion Investigative Site

Zutphen, Netherlands

Cardurion Investigative Site

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

And 39 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejection Fraction (Cycle-1-REF)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (139)