Effectiveness of CRD-740 in Heart Failure

(CARDINAL-HF Trial)

Recruiting at 105 trial locations

Overseen By Pirouz Shamszad, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cardurion Pharmaceuticals, Inc.

Must be taking: Heart failure therapy

Disqualifiers: Recent HF exacerbation, planned interventions, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should be on stable doses of heart failure therapy for at least 4 weeks before screening, suggesting you may need to continue your current treatment.

What is the purpose of this trial?

This trial tests a new medication, CRD-740, in patients with two types of heart failure. It aims to see if the medication helps by measuring certain substances in the blood that indicate heart function.

Research Team

Howard Surks, MD

Principal Investigator

Chief Medical and Scientific Officer

Eligibility Criteria

Inclusion Criteria

Subjects with atrial fibrillation or flutter at screening are required to have an NT-proBNP level of ≥500 pg/mL at 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.

You have echocardiographic evidence of left atrial enlargement.

Exclusion Criteria

Presence of or plan for mechanical circulatory support

Documented EF≥60% within 6 months of screening

Recent HF exacerbation defined by hospitalization or requirement for intravenous diuretics within 60 days of screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CRD-740 or placebo at two ascending dose levels over 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CRD-740
• Placebo

Participant Groups

Group I: CRD-740 Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Cardurion Pharmaceuticals, Inc.

Lead Sponsor

Trials

6

Recruited

740+