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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

NCT03984591 · Status: ENROLLING_BY_INVITATION · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7200

Last updated 2023-02-01

No results posted yet for this study

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.

Conditions

  • Systolic Heart Failure

Interventions

DRUG

Eplerenone

Eplerenone according to guidelines

DRUG

Spironolactone

Spironolactone according to guidelines

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Jens Jakob Thune, MD, PhD · Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03984591 on ClinicalTrials.gov