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

ENROLLING_BY_INVITATIONPHASE4

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?

NCT03984591•Bispebjerg Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

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

Locations (1)

Bispebjerg Hospital

Copenhagen, Denmark

Key Dates

Start Date

November 1, 2020

Primary Completion Date

December 31, 2028

Completion Date

December 31, 2028

Last Updated

February 1, 2023

Enrollment

7,200

ESTIMATED participants

Conditions

Systolic Heart Failure

Interventions

Eplerenone

DRUG

Spironolactone

DRUG

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COMPLETED

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 1, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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