Effectiveness of CRD-740 in Heart Failure (CARDINAL-HF)

November 26, 2024 updated by: Cardurion Pharmaceuticals, Inc.

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnepeg, Manitoba, Canada, R2H 2A6
        • Cardurion Investigative Site
  • Israel
      • Ashkelon, Israel, 7830604
        • Cardurion Investigative Site
      • Be'er Ya'aqov, Israel, 70300
        • Cardurion Investigative Site
      • Haifa, Israel, 31096
        • Cardurion Investigative Site
      • Haifa, Israel, 31999
        • Cardurion Investigative Site
      • Nahariya, Israel, 2210001
        • Cardurion Investigative Site
      • Reẖovot, Israel, 76100
        • Cardurion Investigative Site
      • Tiberias, Israel, 15208
        • Cardurion Investigative Site
  • United Kingdom
      • Clydebank, United Kingdom, G81 4DY
        • Cardurion Investigative Site
      • Dundee, United Kingdom, DD1 4HN
        • Cardurion Investigative Site
      • Glasgow, United Kingdom, G4 0SF
        • Cardurion Investigative Site
      • Harrow, United Kingdom, HA1 3UJ
        • Cardurion Investigative Site
      • Newcastle Upon Tyne, United Kingdom, NE1 4LP
        • Cardurion Investigative Site
      • Stockton-on-Tees, United Kingdom, TS19 8PE
        • Cardurion Investigative Site
    • Buckinghamshire
      • High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT
        • Cardurion Investigative Site
    • Lanarkshire
      • Airdrie, Lanarkshire, United Kingdom, ML6 8LL
        • Cardurion Investigative Site
    • Middlesex
      • Isleworth, Middlesex, United Kingdom, TW7 6AF
        • Cardurion Investigative Site
  • United States
    • Alabama
      • Alexander City, Alabama, United States, 35010
        • Cardurion Investigative Site
      • Birmingham, Alabama, United States, 35211
        • Cardurion Investigative Site
      • Fairhope, Alabama, United States, 36532
        • Cardurion Investigative Site
    • California
      • Torrance, California, United States, 90502
        • Cardurion Investigative Site
    • Florida
      • Hialeah, Florida, United States, 33016
        • Cardurion Investigative Site
      • Miami, Florida, United States, 33133
        • Cardurion Investigative Site
      • Miami, Florida, United States, 33169
        • Cardurion Investigative Site
      • Naples, Florida, United States, 34102
        • Cardurion Investigative Site
      • Tampa, Florida, United States, 33612
        • Cardurion Investigative Site
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Cardurion Investigative Site
    • Illinois
      • Hazel Crest, Illinois, United States, 60429
        • Cardurion Investigative Site
    • Louisiana
      • Alexandria, Louisiana, United States, 71301
        • Cardurion Investigative Site
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Cardurion Investigative Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Cardurion Investigative Site
    • Tennessee
      • Tullahoma, Tennessee, United States, 37388
        • Cardurion Investigative Site
    • Texas
      • Allen, Texas, United States, 75013
        • Cardurion Investigative Site
    • Virginia
      • Norfolk, Virginia, United States, 23504
        • Cardurion Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CRD-740
Part A: Participants in Part A randomly assigned to this arm will take CRD-740 at two ascending dose levels over 12 weeks.
Drug: CRD-740
Tablets administered orally.
Placebo Comparator: Placebo
Part A: Participants in Part A randomly assigned to this arm will take placebo at two ascending dose levels over 12 weeks.
Drug: Placebo
Tablets administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Part A: The Mean Change From Baseline (Day 1) in Plasma cGMP at Week 4.
Time Frame: Baseline to Week 4
Efficacy: To assess the effect of CRD-740 compared to placebo in plasma cGMP at Week 4 in subjects with CHFrEF.
Baseline to Week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Part B: The change from baseline (Day 1) in plasma BNP at Week 12.
Time Frame: Baseline to Week 12
Baseline to Week 12
Part B: The change from baseline (Day 1) in plasma cGMP at Week 12.
Time Frame: Baseline to Week 12
Baseline to Week 12
Part B: The change from baseline (Day 1) in the KCCQ-23-CS at Week 12.
Time Frame: Baseline to Week 12
Baseline to Week 12
Part B: The proportion of subjects with ≥5-point improvement from baseline in the KCCQ-23- CS at Week 12.
Time Frame: Baseline to Week 12
Baseline to Week 12

Other Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Baseline to Week 12
Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardurion Pharmaceuticals, Inc.

Investigators

  • Study Director: Howard Surks, MD, Chief Medical and Scientific Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2022

Primary Completion (Actual)

May 2, 2023

Study Completion (Actual)

July 25, 2023

Study Registration Dates

First Submitted

June 3, 2022

First Submitted That Met QC Criteria

June 3, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

November 26, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD-740-201
  • 2021-005768-23 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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