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
• Status: Enrolling by invitation
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Systolic
• Systolic Heart Failure
• Systolic Murmurs

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