Study to Evaluate the Effect of Dapagliflozin on the Incidence of Worsening Heart Failure or Cardiovascular Death in Patients With Chronic Heart Failure

(DAPA-HF Trial)

Recruiting in Palo Alto (17 mi)

+339 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of worsening heart failure or cardiovascular death in patients with chronic heart failure with reduced ejection fraction

Eligibility Criteria

Inclusion Criteria

Provision of signed informed consent prior to any study specific procedures

Male or female, aged ≥18 years

Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months

Treatment Details

Interventions

• Dapagliflozin (SGLT2 Inhibitor)
• Placebo (Drug)

Participant Groups

Group I: Dapagliflozin Experimental Treatment 1 Intervention

Patients will be randomized 1:1 to either dapagliflozin or placebo.

Group II: Placebo Placebo Group 1 Intervention

Placebo matching dapagliflozin.

Dapagliflozin is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Forxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

🇺🇸 Approved in United States as Farxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

🇨🇦 Approved in Canada as Farxiga for:

• Type 2 diabetes
• Heart failure
• Chronic kidney disease

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Research Site Naples, FL

Research Site New Smyrna Beach, FL

Research Site Bangor, ME

Research Site Lansing, MI

More Trial Locations

Who Is Running the Clinical Trial?

AstraZeneca Lead Sponsor

References