Effectiveness of CRD-740 in Heart Failure

Heart Failure Clinical Trial

— CARDINAL-HF  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05409183
• Other study ID #: CRD-740-201
• Secondary ID: 2021-005768-23
• Status: Terminated
• Phase: Phase 2
• Start date: May 26, 2022
• Est. completion date: July 25, 2023

Study information

• Verified date: November 2023
• Source: Cardurion Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: July 25, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

4. 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.

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:

1. Documented EF=60% within 6 months of screening.

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• CRD-740
Tablets administered orally.
• Placebo
Tablets administered orally.

Locations

Country	Name	City	State
Canada	Cardurion Investigative Site	Winnepeg	Manitoba
Israel	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	Re?ovot
Israel	Cardurion Investigative Site	Tiberias
United Kingdom	Cardurion Investigative Site	Airdrie	Lanarkshire
United Kingdom	Cardurion Investigative Site	Clydebank
United Kingdom	Cardurion Investigative Site	Dundee
United Kingdom	Cardurion Investigative Site	Glasgow
United Kingdom	Cardurion Investigative Site	Harrow
United Kingdom	Cardurion Investigative Site	High Wycombe	Buckinghamshire
United Kingdom	Cardurion Investigative Site	Isleworth	Middlesex
United Kingdom	Cardurion Investigative Site	Newcastle Upon Tyne
United Kingdom	Cardurion Investigative Site	Stockton-on-Tees
United States	Cardurion Investigative Site	Alexander City	Alabama
United States	Cardurion Investigative Site	Alexandria	Louisiana
United States	Cardurion Investigative Site	Allen	Texas
United States	Cardurion Investigative Site	Atlanta	Georgia
United States	Cardurion Investigative Site	Birmingham	Alabama
United States	Cardurion Investigative Site	Fairhope	Alabama
United States	Cardurion Investigative Site	Greensboro	North Carolina
United States	Cardurion Investigative Site	Hazel Crest	Illinois
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	Minneapolis	Minnesota
United States	Cardurion Investigative Site	Naples	Florida
United States	Cardurion Investigative Site	Norfolk	Virginia
United States	Cardurion Investigative Site	Tampa	Florida
United States	Cardurion Investigative Site	Torrance	California
United States	Cardurion Investigative Site	Tullahoma	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Cardurion Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Israel,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Part A: The change in NT-proBNP from baseline (Day 1) to Week 2, from Week 2 to Week 4, and from Week 2 to Week 12.		Baseline to Week 12
Primary	Part A: The change from baseline (Day -1) in plasma cGMP at Week 4.		Baseline to Week 4
Primary	Part B: The change from baseline (Day 1) in NT-proBNP at Week 12.		Baseline to Week 12
Secondary	Part B: The change from baseline (Day 1) in plasma BNP at Week 12.		Baseline to Week 12
Secondary	Part B: The change from baseline (Day 1) in plasma cGMP at Week 12.		Baseline to Week 12
Secondary	Part B: The change from baseline (Day 1) in the KCCQ-23-CS at Week 12.		Baseline to Week 12
Secondary	Part B: The proportion of subjects with =5-point improvement from baseline in the KCCQ-23- CS at Week 12.		Baseline to Week 12