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

Bispebjerg Hospital

Status and phase: Invitation-only; Phase 4

Conditions: Systolic Heart Failure

Treatments: Drug: Spironolactone; Drug: Eplerenone

Study type: Interventional

Funder types: Other

Identifiers

NCT03984591

CROWD-ASPECT

Details and patient eligibility

About

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.

Enrollment: 7,200 estimated patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7,200 participants in 2 patient groups

Spironolactone

Active Comparator group

Description:

Spironolactone used according to heart failure guidelines

Treatment:

Drug: Spironolactone

Eplerenone

Active Comparator group

Description:

Eplerenone used according to heart failure guidelines

Treatment:

Drug: Eplerenone