Overview

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:

Participant gender:

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

Details

Lead Sponsor:

Bispebjerg Hospital

Collaborator:

Rigshospitalet, Denmark

Treatments:

Eplerenone
Spironolactone