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.

Phase 1

• Conditions: Chronic Heart Failure (HF) with Reduced Ejection Fraction; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003897-41-SK
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-12
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 4500

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

• 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 clinical trial of medicinal product
• Study Design: Not specified