NCT03984591

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

Cluster and Registry Trials Of the Working Group of Heart Failure in Denmark: Are SPironolactone and Eplerenone Comparable Treatments?

• Status: Enrolling By Invitation
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 7,200 (estimated)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Systolic Heart Failure

Interventions

Type	Name	Description
DRUG	Eplerenone	Eplerenone according to guidelines
DRUG	Spironolactone	Spironolactone according to guidelines

Timeline

• Start date: 2020-11-01
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2019-06-13
• Last updated: 2023-02-01

Locations

1 site across 1 country: Denmark