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

Phase 4Enrolling By InvitationNCT03984591

Bispebjerg Hospital7,200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

7,200

Conditions

Systolic Heart Failure

Interventions

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Mortality

Mortality (will be used if overall mortality rate is 15% or greater)

Time frame: 5 years

Mortality or hospitalization for heart failure

Will be used if overall mortality is less than 15%

Time frame: 6 years