A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure
- Registration Number
- NCT03984591
- Lead Sponsor
- Bispebjerg Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 7200
- 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
- patients who had filled in a prescription for an aldosterone antagonist prior ro registration in the Danish Heart Failure Registry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Spironolactone Spironolactone Spironolactone used according to heart failure guidelines Eplerenone Eplerenone Eplerenone used according to heart failure guidelines
- Primary Outcome Measures
Name Time Method Mortality 5 years Mortality (will be used if overall mortality rate is 15% or greater)
Mortality or hospitalization for heart failure 6 years Will be used if overall mortality is less than 15%
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Bispebjerg Hospital
🇩🇰Copenhagen, Denmark