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NCT03984591 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

Systolic Heart Failure Clinical Trial

— CROWD-ASPECT  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03984591
Other study ID # CROWD-ASPECT
Secondary ID
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date November 1, 2020
Est. completion date December 31, 2028

Study information
Verified date January 2023
Source Bispebjerg Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 7200
Est. completion date December 31, 2028
Est. primary completion date December 31, 2028
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Eplerenone
Eplerenone according to guidelines
• Spironolactone
Spironolactone according to guidelines

Locations
Country Name City State
Denmark Bispebjerg Hospital Copenhagen

Sponsors (2)
Lead Sponsor Collaborator
Bispebjerg Hospital Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Mortality (will be used if overall mortality rate is 15% or greater) 5 years
Primary Mortality or hospitalization for heart failure Will be used if overall mortality is less than 15% 6 years
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