DAPA-HF

Phase 3

Completed

• Conditions: Chronic Heart Failure With Reduced Ejection Fraction (HFrEF)

• Registration Number: JPRN-jRCT2080223469
• Lead Sponsor: AstraZeneca KK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-01
• Study Completion: 2019-07-17
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 330

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

- 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>exploratory<br>-

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>exploratory<br>-