Clinical trial NCT05409183: Effectiveness of CRD-740 in Heart Failure
Official title: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Heart Failure
Heart Failure With Reduced Ejection Fraction
Heart Failure With Preserved Ejection Fraction
Cardiovascular Diseases
Heart Diseases
Keywords: PDE9
Heart Failure
CRD-740
HFpEF
HFrEF
Lead sponsor: Cardurion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

1. Males or Females ≥18 years of age, at screening.
2. Diagnosis of clinical heart failure syndrome, New York Heart Association functional class II - III for at least 6 months prior to screening
3. 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 Criteria:

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.

Primary outcomes:
measure: Part A: The Mean Change From Baseline (Day 1) in Plasma cGMP at Week 4.
timeFrame: Baseline to Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Cardurion Investigative Site
state: Alabama
city: Birmingham
country: United States
facility: Cardurion Investigative Site
state: Alabama
city: Fairhope
country: United States
facility: Cardurion Investigative Site
state: Alabama
city: Torrance
country: United States
facility: Cardurion Investigative Site
state: California
city: Hialeah
country: United States
facility: Cardurion Investigative Site
state: Florida
city: Miami
country: United States
facility: Cardurion Investigative Site
state: Florida
city: Miami
country: United States
facility: Cardurion Investigative Site
state: Florida
city: Naples
country: United States
facility: Cardurion Investigative Site
state: Florida
city: Tampa
country: United States
facility: Cardurion Investigative Site
state: Florida
city: Atlanta
country: United States
facility: Cardurion Investigative Site
state: Georgia
city: Hazel Crest
country: United States
facility: Cardurion Investigative Site
state: Illinois
city: Alexandria
country: United States
facility: Cardurion Investigative Site
state: Louisiana
city: Minneapolis
country: United States
facility: Cardurion Investigative Site
state: Minnesota
city: Greensboro
country: United States
facility: Cardurion Investigative Site
state: North Carolina
city: Tullahoma
country: United States
facility: Cardurion Investigative Site
state: Tennessee
city: Allen
country: United States
facility: Cardurion Investigative Site
state: Texas
city: Norfolk
country: United States
facility: Cardurion Investigative Site
state: Virginia
city: Winnepeg
country: Canada
facility: Cardurion Investigative Site
state: Manitoba
city: Ashkelon
country: Israel
facility: Cardurion Investigative Site
city: Be'er Ya'aqov
country: Israel
facility: Cardurion Investigative Site
city: Haifa
country: Israel
facility: Cardurion Investigative Site
city: Haifa
country: Israel
facility: Cardurion Investigative Site
city: Nahariya
country: Israel
facility: Cardurion Investigative Site
city: Reẖovot
country: Israel
facility: Cardurion Investigative Site
city: Tiberias
country: Israel
facility: Cardurion Investigative Site
city: High Wycombe
country: United Kingdom
facility: Cardurion Investigative Site
state: Buckinghamshire
city: Airdrie
country: United Kingdom
facility: Cardurion Investigative Site
state: Lanarkshire
city: Isleworth
country: United Kingdom
facility: Cardurion Investigative Site
state: Middlesex
city: Clydebank
country: United Kingdom
facility: Cardurion Investigative Site
city: Dundee
country: United Kingdom
facility: Cardurion Investigative Site
city: Glasgow
country: United Kingdom
facility: Cardurion Investigative Site
city: Harrow
country: United Kingdom
facility: Cardurion Investigative Site
city: Newcastle Upon Tyne
country: United Kingdom
facility: Cardurion Investigative Site
city: Stockton-on-Tees
country: United Kingdom
facility: Cardurion Investigative Site
Study officials:
affiliation: Chief Medical and Scientific Officer
name: Howard Surks, MD
role: STUDY_DIRECTOR
References: