Study to evaluate if dapagliflozin treatment is effective in patients with heart failure by reducing the number of hospitalizations and urgent visits due to heart failure, and by reducing the risk of death.

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 - DAPA HF

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003897-41-SE

Enrollment

4500

Registered

2016-11-28

Start date

2017-01-19

Completion date

Unknown

Last updated

2019-12-16

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

Conditions

Chronic Heart Failure (HF) with Reduced Ejection Fraction

Interventions

Trade Name: Forxiga Product Name: Dapagliflozin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DAPAGLIFLOZIN PROPANEDIOL C

Eligibility

Sex/Gender

All

Inclusion 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 • LVEF=40% • Elevated N-terminal pro b-type natriuretic peptide (NT-proBNP) levels • Patients should receive background standard of care for HFrEF and be treated according to locally recognized guidelines. • eGFR =30 ml/min/1.73 m2 (CKD-EPI formula) at enrolment (visit 1) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2250

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
Main Objective: To determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the incidence of CV death or a HF event (hospitalization for HF or equivalent HF event, ie an urgent HF visit).; Secondary Objective: 1) To compare the effect of dapagliflozin versus placebo on CV death or hospitalization for HF. 2) To compare the effect of dapagliflozin versus placebo on total number of recurrent HF hospitalizations and CV death. 3) To compare the effect of treatment with dapagliflozin versus placebo on the KCCQ total symptom score for HF symptoms and physical limitations. 4) To determine if dapagliflozin compared with placebo reduces the incidence of a worsening renal function composite outcome. 5) To determine whether dapagliflozin, compared with placebo, reduces the incidence of all cause mortality. ; Primary end point(s): Time to the first occurrence of any of the components of this composite: 1. CV death 2. Hospitalization for HF 3. An urgent HF visit ; Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated after at least 844 primary endpoint events are accrued.	—

Measure

Time frame

Main Objective: To determine whether dapagliflozin is superior to placebo, when added to standard of care, in reducing the incidence of CV death or a HF event (hospitalization for HF or equivalent HF event, ie an urgent HF visit).; Secondary Objective: 1) To compare the effect of dapagliflozin versus placebo on CV death or hospitalization for HF. 2) To compare the effect of dapagliflozin versus placebo on total number of recurrent HF hospitalizations and CV death. 3) To compare the effect of treatment with dapagliflozin versus placebo on the KCCQ total symptom score for HF symptoms and physical limitations. 4) To determine if dapagliflozin compared with placebo reduces the incidence of a worsening renal function composite outcome. 5) To determine whether dapagliflozin, compared with placebo, reduces the incidence of all cause mortality. ; Primary end point(s): Time to the first occurrence of any of the components of this composite: 1. CV death 2. Hospitalization for HF 3. An urgent HF visit ; Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated after at least 844 primary endpoint events are accrued.

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Secondary

Measure	Time frame
Secondary end point(s): 1) Time to the first occurrence of either of the components of this composite: 1. CV death 2. Hospitalization for HF 2) Total number of (first and recurrent) HF hospitalizations and CV death. 3) Change from baseline measured at 8 months in the overall summary score of the KCCQ, a specific HF patient reported outcome questionnaire. 4) Time to the first occurrence of any of the components of this composite: 1. =50% sustained decline in eGFR 2. Reaching End Stage Renal Disease (ESRD) ? - Sustained eGFR <15 ml/min/1.73m2 or, ? - Chronic dialysis treatment or, ? - Receiving a renal transplant 3. Renal death 5) Time to death from any cause. ; Timepoint(s) of evaluation of this end point: Change from baseline of the total symptom score of the KCCQ will be evaluated at 8 months after randomization. All other secondary endpoints will be evaluated after at least 844 primary endpoint events are accrued.	—

Measure

Time frame

Secondary end point(s): 1) Time to the first occurrence of either of the components of this composite: 1. CV death 2. Hospitalization for HF 2) Total number of (first and recurrent) HF hospitalizations and CV death. 3) Change from baseline measured at 8 months in the overall summary score of the KCCQ, a specific HF patient reported outcome questionnaire. 4) Time to the first occurrence of any of the components of this composite: 1. =50% sustained decline in eGFR 2. Reaching End Stage Renal Disease (ESRD) ? - Sustained eGFR <15 ml/min/1.73m2 or, ? - Chronic dialysis treatment or, ? - Receiving a renal transplant 3. Renal death 5) Time to death from any cause. ; Timepoint(s) of evaluation of this end point: Change from baseline of the total symptom score of the KCCQ will be evaluated at 8 months after randomization. All other secondary endpoints will be evaluated after at least 844 primary endpoint events are accrued.

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Countries

Argentina, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Germany, Hungary, India, Japan, Netherlands, Poland, Russian Federation, Slovakia, Sweden, Taiwan, United Kingdom, United States, Vietnam

Contacts

Public ContactInformation Center

AstraZeneca

information.center@astrazeneca.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026