A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure

• Status: Enrolling by invitation
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Objective The objective is to compare the efficacy of spironolactone and eplerenone on clinical outcome in patients with heart failure and a reduced ejection fraction.

Method The study is a crossover cluster randomized trial. Each heart failure clinic in Denmark will be allocated to four periods (clusters): two periods with spironolactone and two periods with eplerenone as first drug. The planned total participation time for each department is 4 years and we estimate that data from 7200 patients will be accrued in this period. Endpoints will be assessed through Danish National Registries.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bispebjerg Hospital
• Collaborator: Rigshospitalet, Denmark
• Treatments: Eplerenone; Spironolactone

Criteria

Inclusion Criteria:

• all patients registered in the Danish Heart Failure Registry who has a baseline left ventricular ejection fraction <40% and who has filled in a prescription for an aldosterone antagonist

Exclusion Criteria:

• patients who had filled in a prescription for an aldosterone antagonist prior ro registration in the Danish Heart Failure Registry