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Enrolling by Invitation

NCT Number: NCT03984591

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

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.

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Key information

Conditions

Systolic Heart Failure Cardiovascular Diseases Heart Diseases Heart Failure Heart Failure, Systolic

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eplerenone

Drug

Eplerenone according to guidelines

Spironolactone

Drug

Spironolactone according to guidelines

Primary outcomes

  1. Mortality

    Time frame: 5 years

    Mortality (will be used if overall mortality rate is 15% or greater)

  2. Mortality or hospitalization for heart failure

    Time frame: 6 years

    Will be used if overall mortality is less than 15%

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

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

Acronym: CROWD-ASPECT

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Jun 13, 2019
Registry last updated
Feb 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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