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Trial record 2 of 2 for:    CRD-740

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05409183
Recruitment Status : Recruiting
First Posted : June 8, 2022
Last Update Posted : June 8, 2022
Sponsor:
Information provided by (Responsible Party):
Cardurion Pharmaceuticals, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Failure Heart Failure With Reduced Ejection Fraction Heart Failure With Preserved Ejection Fraction Cardiovascular Diseases Heart Diseases Drug: CRD-740 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : May 26, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: CRD-740

Part A: Participants in Part A randomly assigned to this arm will take CRD-740 twice daily at two ascending dose levels over 12 weeks.

Part B: Participants in Part B randomly assigned to this arm will take CRD-740 twice daily at a single dose level 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 twice daily at two ascending dose levels over 12 weeks.

Part B: Participants in Part B randomly assigned to this arm will take placebo twice daily at a single dose level over 12 weeks.

Drug: Placebo
Tablets administered orally.




Primary Outcome Measures :
  1. Part A: The change from baseline (Day -1) in plasma cGMP at Week 4. [ Time Frame: Baseline to Week 4 ]
  2. Part B: The change from baseline (Day 1) in NT-proBNP at Week 12. [ Time Frame: Baseline to Week 12 ]

Secondary Outcome Measures :
  1. Part B: The change from baseline (Day 1) in plasma BNP at Week 12. [ Time Frame: Baseline to Week 12 ]
  2. Part B: The change from baseline (Day 1) in plasma cGMP at Week 12. [ Time Frame: Baseline to Week 12 ]
  3. Part B: The change from baseline (Day 1) in the KCCQ-23-CS at Week 12. [ Time Frame: Baseline to Week 12 ]
  4. 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 ]

Other Outcome Measures:
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05409183


Contacts
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Contact: Pirouz Shamszad, MD 617-863-8088 info@cardurion.com

Locations
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Sponsors and Collaborators
Cardurion Pharmaceuticals, Inc.
Investigators
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Study Director: Pirouz Shamszad, MD Executive Director, Clinical Research
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Responsible Party: Cardurion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT05409183    
Other Study ID Numbers: CRD-740-201
2021-005768-23 ( EudraCT Number )
First Posted: June 8, 2022    Key Record Dates
Last Update Posted: June 8, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cardurion Pharmaceuticals, Inc.:
PDE9
Heart Failure
CRD-740
HFpEF
HFrEF
Additional relevant MeSH terms:
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Heart Failure
Cardiovascular Diseases
Heart Diseases