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

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

Status

Enrolling by invitation

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03984591

Acronym

CROWD-ASPECT

Enrollment

7200

Registered

2019-06-13

Start date

2020-11-01

Completion date

2028-12-31

Last updated

2023-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systolic Heart Failure

Keywords

aldosterone antagonists, spironolactone, eplerenone, mortality

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.

Interventions

DRUGEplerenone

Eplerenone according to guidelines

DRUGSpironolactone

Spironolactone according to guidelines

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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

Exclusion criteria

* patients who had filled in a prescription for an aldosterone antagonist prior ro registration in the Danish Heart Failure Registry

Design outcomes

Primary

Measure	Time frame	Description
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%

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026