CROWD-ASPECT: 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 (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03984591

Collaborator

Rigshospitalet, Denmark (Other)

7,200

Enrollment

Location

Arms

Anticipated Duration (Months)

98.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systolic Heart Failure	Drug: Eplerenone Drug: Spironolactone	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

7200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Spironolactone Spironolactone used according to heart failure guidelines	Drug: Spironolactone Spironolactone according to guidelines
Active Comparator: Eplerenone Eplerenone used according to heart failure guidelines	Drug: Eplerenone Eplerenone according to guidelines

Arm

Intervention/Treatment

Active Comparator: Spironolactone

Spironolactone used according to heart failure guidelines

Drug: Spironolactone

Spironolactone according to guidelines

Active Comparator: Eplerenone

Eplerenone used according to heart failure guidelines

Drug: Eplerenone

Eplerenone according to guidelines

Outcome Measures

Primary Outcome Measures

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%

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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