Clinical Trial

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

Study acronym: CROWD-ASPECT
Enrolling by Invitation Phase 4
View on ClinicalTrials.gov →
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2019-06-11; most recent amendment 2023-01-30.
Status change: Not Yet Recruiting → Enrolling by Invitation 2021-08-09
Trial Details
NCT Number NCT03984591
Lead Sponsor Bispebjerg Hospital
Collaborators: Rigshospitalet, Denmark
Conditions Systolic Heart Failure
Enrollment 7,200 participants
Start Date 2020-11-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2023-02-01