DAPA-HF

Study 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223469

Enrollment

330

Registered

2017-03-01

Start date

2017-03-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

Interventions

investigational material(s) Generic name etc : Dapagliflozin INN of investigational material : - Therapeutic category code : 219 Other cardiovascular agents Dosage and Administration for Investigation

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Provision of signed informed consent prior to any study specific procedures - Established documented diagnosis of symptomatic HFrEF (NYHA functional class II-IV), which has been present for at least 2 months - LVEF less than 40% - NT-proBNP 600 pg/ml or more - Patients should receive background standard of care for HFrEF - eGFR 30 ml/min/1.73 m2 (CKD-EPI formula) or more at enrolment (visit 1)

Exclusion criteria

Exclusion criteria: - Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor - Type 1 diabetes mellitus - Symptomatic hypotension or systolic BP <95 mmHg - Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment - MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment - Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization - Implantation of a cardiac CRT within 12 weeks prior to enrolment or intent to implant a CRT device - Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization - HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease - Symptomatic bradycardia or second or third degree heart block without a pacemaker - Severe (eGFR <30 mL/min/1.73 m2 by CKD-EPI), unstable or rapidly progressing renal disease at the time of randomization

Design outcomes

Primary

Measure	Time frame
safety efficacy exploratory -	—

Secondary

Measure	Time frame
safety efficacy exploratory -	—

Countries

Asia except Japan, Europe, Japan, North America, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026