Effectiveness of CRD-740 in Heart Failure

NCT05409183 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: CRD-740-201
• Study Type: interventional
• Target: 60
• Locations: 4 countries
• Sites: 34

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.

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

Outcome Measures

Primary Outcomes (1)

• Part A: The Mean Change From Baseline (Day 1) in Plasma cGMP at 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

Study Arms (2)

CRD-740

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Part A: Participants in Part A randomly assigned to this arm will take placebo at two ascending dose levels over 12 weeks.

Drug: Placebo

Interventions

CRD-740 DRUG

Tablets administered orally.

CRD-740

Placebo DRUG

Tablets administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Cardurion Pharmaceuticals, Inc.: lead

Study Sites (34)

Cardurion Investigative Site

Alexander City, Alabama, 35010, United States

Location

Cardurion Investigative Site

Birmingham, Alabama, 35211, United States

Location

Cardurion Investigative Site

Fairhope, Alabama, 36532, United States

Location

Cardurion Investigative Site

Torrance, California, 90502, United States

Location

Cardurion Investigative Site

Hialeah, Florida, 33016, United States

Location

Cardurion Investigative Site

Miami, Florida, 33133, United States

Location

Cardurion Investigative Site

Miami, Florida, 33169, United States

Location

Cardurion Investigative Site

Naples, Florida, 34102, United States

Location

Cardurion Investigative Site

Tampa, Florida, 33612, United States

Location

Cardurion Investigative Site

Atlanta, Georgia, 30303, United States

Location

Cardurion Investigative Site

Hazel Crest, Illinois, 60429, United States

Location

Cardurion Investigative Site

Alexandria, Louisiana, 71301, United States

Location

Cardurion Investigative Site

Minneapolis, Minnesota, 55415, United States

Location

Cardurion Investigative Site

Greensboro, North Carolina, 27408, United States

Location

Cardurion Investigative Site

Tullahoma, Tennessee, 37388, United States

Location

Cardurion Investigative Site

Allen, Texas, 75013, United States

Location

Cardurion Investigative Site

Norfolk, Virginia, 23504, United States

Location

Cardurion Investigative Site

Winnepeg, Manitoba, R2H 2A6, Canada

Location

Cardurion Investigative Site

Ashkelon, 7830604, Israel

Location

Cardurion Investigative Site

Be’er Ya‘aqov, 70300, Israel

Location

Cardurion Investigative Site

Haifa, 31096, Israel

Location

Cardurion Investigative Site

Haifa, 31999, Israel

Location

Cardurion Investigative Site

Nahariya, 2210001, Israel

Location

Cardurion Investigative Site

Rehovot, 76100, Israel

Location

Cardurion Investigative Site

Tiberias, 15208, Israel

Location

Cardurion Investigative Site

High Wycombe, Buckinghamshire, HP11 2TT, United Kingdom

Location

Cardurion Investigative Site

Airdrie, Lanarkshire, ML6 8LL, United Kingdom

Location

Cardurion Investigative Site

Isleworth, Middlesex, TW7 6AF, United Kingdom

Location

Cardurion Investigative Site

Clydebank, G81 4DY, United Kingdom

Location

Cardurion Investigative Site

Dundee, DD1 4HN, United Kingdom

Location

Cardurion Investigative Site

Glasgow, G4 0SF, United Kingdom

Location

Cardurion Investigative Site

Harrow, HA1 3UJ, United Kingdom

Location

Cardurion Investigative Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Cardurion Investigative Site

Stockton-on-Tees, TS19 8PE, United Kingdom

Location

Related Publications (1)

• Udelson JE, Belohlavek J, Dukat A, Ezekowitz J, Goland S, Merkely B, O'Meara E, Petrie MC, Ponikowski P, Senni M, Tokmakova M, Vardeny O, Claggett B, Moore E, Savard M, McKellar H, Surks HK, Solomon SD, McMurray JJV. Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of CRD-740, a PDE9 Inhibitor, in Chronic Heart Failure. JACC Heart Fail. 2026 Jan;14(1):102706. doi: 10.1016/j.jchf.2025.102706. Epub 2025 Oct 31.

  PMID: 41171251 DERIVED

MeSH Terms

Conditions

Heart Failure; Cardiovascular Diseases; Heart Diseases

Limitations and Caveats

This study was planned to have been conducted in 2 parts: Part A and Part B. Part A was a dose ranging study in a group of subjects with CHFrEF. Part B was planned to be a proof-of-concept study in subjects with either CHFrEF or CHFpEF. Part B of the study was not conducted in favor of redesigned new studies.

Results Point of Contact

• Title: James Udelson, MD
• Organization: Tufts Medical Center

James.Udelson@tuftsmedicine.org

(617) 636-8066

Study Officials

• Howard Surks, MD

  Chief Medical and Scientific Officer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2022
• First Posted: June 8, 2022
• Study Start: May 26, 2022
• Primary Completion: May 2, 2023
• Study Completion: July 25, 2023
• Last Updated: December 19, 2024
• Results First Posted: December 19, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (9); US (17); CA (1); IL (7)