Effectiveness of CRD-740 in Heart Failure

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction, Cardiovascular Diseases, Heart Diseases

In brief

This is a study evaluating the effectiveness of CRD-740 in patients with either Heart Failure with Reduced Ejection Fraction (HFrEF) or Heart Failure with Preserved Ejection Fraction (HFpEF) after 12 weeks of treatment. The primary objective in Part A is to assess the effect of CRD-740 compared to placebo in plasma cGMP at Week 4 in HFrEF. Part B of the study was not conducted in favor of redesigned new studies.

Key facts

Study ID

NCT05409183

Run by

Cardurion Pharmaceuticals, Inc.

People needed

60

Starts

2022-05-26

Expected to finish

2023-07-25

Last updated by the study team

2024-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or Females ≥18 years of age, at screening.
• Diagnosis of clinical heart failure syndrome, New York Heart Association functional class II - III for at least 6 months prior to screening
• For Part A:
• Ejection Fraction ≤40% by echocardiography at screening.
• NT-proBNP level ≥600 pg/ml at screening. Subjects with atrial fibrillation or flutter at screening are required to have an NT-proBNP level of ≥1000 pg/mL at screening.
• Stable doses of guideline-directed heart failure therapy for a minimum of 4 weeks prior to screening that has been individually optimized according to standard practice guidelines and no addition of guideline-directed heart failure therapy within 3 months of screening.

You may not qualify if…

• Recent HF exacerbation defined by hospitalization or requirement for intravenous diuretics within 60 days of screening.
• Subjects with planned interventions (e.g., percutaneous coronary intervention, devices) etc. occurring during their involvement in this study.
• Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery or carotid angioplasty within 60 days of screening.
• Subjects with clinical suspicion of infiltrative cardiomyopathy (e.g., amyloid, sarcoid), hypertrophic cardiomyopathy (obstructive or non-obstructive), or HF secondary to severe valvular disease, active myocarditis, active pericarditis, or clinically significant congenital heart disease.
• Prior or planned orthotopic heart transplantation.
• Presence of or plan for mechanical circulatory support.
• Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Where it is running

• Cardurion Investigative Site — Alexander City, Alabama, United States
• Cardurion Investigative Site — Birmingham, Alabama, United States
• Cardurion Investigative Site — Fairhope, Alabama, United States
• Cardurion Investigative Site — Torrance, California, United States
• Cardurion Investigative Site — Hialeah, Florida, United States
• Cardurion Investigative Site — Miami, Florida, United States
• Cardurion Investigative Site — Miami, Florida, United States
• Cardurion Investigative Site — Naples, Florida, United States
• Cardurion Investigative Site — Tampa, Florida, United States
• Cardurion Investigative Site — Atlanta, Georgia, United States
• Cardurion Investigative Site — Hazel Crest, Illinois, United States
• Cardurion Investigative Site — Alexandria, Louisiana, United States
• Cardurion Investigative Site — Minneapolis, Minnesota, United States
• Cardurion Investigative Site — Greensboro, North Carolina, United States
• Cardurion Investigative Site — Tullahoma, Tennessee, United States
• Cardurion Investigative Site — Allen, Texas, United States
• Cardurion Investigative Site — Norfolk, Virginia, United States
• Cardurion Investigative Site — Winnepeg, Manitoba, Canada
• Cardurion Investigative Site — Ashkelon, Israel
• Cardurion Investigative Site — Be’er Ya‘aqov, Israel
• Cardurion Investigative Site — Haifa, Israel
• Cardurion Investigative Site — Haifa, Israel
• Cardurion Investigative Site — Nahariya, Israel
• Cardurion Investigative Site — Rehovot, Israel
• Cardurion Investigative Site — Tiberias, Israel

Full record on ClinicalTrials.gov

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