Efficacy, Safety and Tolerability of AZD9977 and Dapagliflozin in Participants With Heart Failure and Chronic Kidney Disease

(MIRACLE Trial)

Recruiting in Palo Alto (17 mi)

+191 other locations

Overseen by John McMurray

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial tests a new drug, AZD9977, combined with dapagliflozin in patients with heart failure and chronic kidney disease. The goal is to see if this combination improves kidney function and heart health better than using dapagliflozin alone. Dapagliflozin is a medication that has been shown to reduce heart-related deaths and heart failure in patients with chronic heart failure.

Research Team

John McMurray

Principal Investigator

University of Glasgow, United Kingdom

Eligibility Criteria

Inclusion Criteria

All participants must follow protocol defined contraceptives procedures

Your body weight is not extremely high for your height.

Documented diagnosis of stable symptomatic HF (New York Heart Association class II-III) at screening, and a medical history of typical symptoms and signs of HF in those who are currently receiving loop diuretic treatment

Exclusion Criteria

You have Type 1 diabetes.

You have a history of dangerous heart rhythm problems or uncontrolled rapid heart rate if you have atrial fibrillation or atrial flutter.

HF due to cardiomyopathies

Treatment Details

Interventions

• AZD9977 (Other)
• Dapagliflozin (Other)
• Placebo (Other)

Participant Groups

Group I: Dapagliflozin 10 mg Experimental Treatment 1 Intervention

Participants will receive once daily oral dose of dapagliflozin 10 mg alone for 12 weeks.

Group II: AZD9977 Dose C + dapagliflozin 10 mg Experimental Treatment 2 Interventions

Participants will receive once daily oral dose C of AZD9977 and 10 mg dapagliflozin for 12 weeks.

Group III: AZD9977 Dose B + dapagliflozin 10 mg Experimental Treatment 2 Interventions

Participants will receive once daily oral dose B of AZD9977 and 10 mg dapagliflozin for 12 weeks.

Group IV: AZD9977 Dose A + dapagliflozin 10 mg Experimental Treatment 2 Interventions

Participants will receive once daily oral dose A of AZD9977 and 10 mg dapagliflozin for 12 weeks.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Research Site Columbus, GA

Research Site Winston-Salem, NC

Research Site Saint Louis, MO

Research Site Poughkeepsie, NY

More Trial Locations

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4491

Patients Recruited

290,540,000+