Status:
TERMINATED
Effectiveness of CRD-740 in Heart Failure
Lead Sponsor:
Cardurion Pharmaceuticals, Inc.
Conditions:
Heart Failure
Heart Failure With Reduced Ejection Fraction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
- 5\. 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
- 2\. Recent HF exacerbation defined by hospitalization or requirement for intravenous diuretics within 60 days of screening.
- 3\. Subjects with planned interventions (e.g., percutaneous coronary intervention, devices) etc. occurring during their involvement in this study.
- 4\. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery or carotid angioplasty within 60 days of screening.
- 5\. 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.
- 6\. Prior or planned orthotopic heart transplantation.
- 7\. Presence of or plan for mechanical circulatory support.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
May 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 25 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05409183
Start Date
May 26 2022
End Date
July 25 2023
Last Update
December 19 2024
Active Locations (34)
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1
Cardurion Investigative Site
Alexander City, Alabama, United States, 35010
2
Cardurion Investigative Site
Birmingham, Alabama, United States, 35211
3
Cardurion Investigative Site
Fairhope, Alabama, United States, 36532
4
Cardurion Investigative Site
Torrance, California, United States, 90502