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CRD-740 for Heart Failure (CARDINAL-HF Trial)
Phase 2
Waitlist Available
Research Sponsored by Cardurion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 12
Awards & highlights
CARDINAL-HF Trial Summary
This trial is testing a drug to see if it can help people with two types of heart failure.
Eligible Conditions
- Heart Failure
- Cardiovascular Disease
- Heart Disease
CARDINAL-HF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: The change from baseline (Day -1) in plasma cGMP at Week 4.
Part B: The change from baseline (Day 1) in NT-proBNP at Week 12.
Secondary outcome measures
Part B: The change from baseline (Day 1) in plasma BNP at Week 12.
Part B: The change from baseline (Day 1) in plasma cGMP at Week 12.
Part B: The change from baseline (Day 1) in the KCCQ-23-CS at Week 12.
+1 moreOther outcome measures
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.
CARDINAL-HF Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CRD-740Experimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CRD-740
2022
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
Cardurion Pharmaceuticals, Inc.Lead Sponsor
4 Previous Clinical Trials
672 Total Patients Enrolled
3 Trials studying Heart Failure
660 Patients Enrolled for Heart Failure
Elizabeth Moore, DNP, CPNP-AC, CPNStudy DirectorSenior Director, Clinical Research
Pirouz Shamszad, MDStudy DirectorExecutive Director, Clinical Research
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Subjects with atrial fibrillation or flutter at screening are required to have an NT-proBNP level of ≥500 pg/mL at screening.You have echocardiographic evidence of left atrial enlargement.Subjects with atrial fibrillation or flutter at screening are required to have an NT-proBNP level of ≥1000 pg/mL at screening.You are at least 18 years of age, and are either male or female.
Research Study Groups:
This trial has the following groups:- Group 1: CRD-740
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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