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A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure
Sponsor: Bispebjerg Hospital
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.
Official title: Cluster and Registry Trials Of the Working Group of Heart Failure in Denmark: Are SPironolactone and Eplerenone Comparable Treatments?
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
7200
Start Date
2020-11-01
Completion Date
2028-12-31
Last Updated
2023-02-01
Healthy Volunteers
No
Conditions
Interventions
Eplerenone
Eplerenone according to guidelines
Spironolactone
Spironolactone according to guidelines
Locations (1)
Bispebjerg Hospital
Copenhagen, Denmark