A Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effectiveness of CRD-740 in Subjects With Chronic Heart Failure (CARDINAL-HF) (CARDINAL-HF)

  • STATUS
    Recruiting
  • End date
    Jan 14, 2024
  • participants needed
    660
  • sponsor
    Cardurion Pharmaceuticals, Inc.
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Updated on 14 October 2022
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ejection fraction
heart failure
nt-probnp

Summary

This is a two-part 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. The primary objective in Part B is to determine whether CRD-740 reduces NT-proBNP compared to placebo at Week 12.

Details
Condition Heart Failure, Heart Failure With Reduced Ejection Fraction, Heart Failure With Preserved Ejection Fraction, Cardiovascular Diseases, Heart Diseases
Treatment Placebo, CRD-740
Clinical Study IdentifierNCT05409183
SponsorCardurion Pharmaceuticals, Inc.
Last Modified on14 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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
For Part B
For subjects with EF ≤40%
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
For subjects with EF >40%
EF >40% and left atrial enlargement by echocardiography at screening
NT-proBNP level ≥300 pg/ml at screening. Subjects with atrial fibrillation or flutter at screening are required to have an NT-proBNP level of ≥500 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

Exclusion Criteria

Documented EF≥60% within 6 months of screening
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
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