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 | Enrolling By Invitation Phase 4 DMC

• 1 other identifier: CROWD-ASPECT
• Study Type: interventional
• Target: 7,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Systolic Heart Failure

Keywords

aldosterone antagonists; spironolactone; eplerenone; mortality

Outcome Measures

Primary Outcomes (2)

• Mortality

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

  5 years

• Mortality or hospitalization for heart failure

  Will be used if overall mortality is less than 15%

  6 years

Study Arms (2)

Spironolactone

ACTIVE COMPARATOR

Spironolactone used according to heart failure guidelines

Drug: Spironolactone

Eplerenone

ACTIVE COMPARATOR

Eplerenone used according to heart failure guidelines

Drug: Eplerenone

Interventions

Eplerenone DRUG

Eplerenone according to guidelines

Eplerenone

Spironolactone DRUG

Spironolactone according to guidelines

Spironolactone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Bispebjerg Hospital

Copenhagen, 2400, Denmark

Location

MeSH Terms

Conditions

Heart Failure, Systolic

Interventions

Eplerenone; Spironolactone

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jens Jakob Thune, MD, PhD

  Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical research associate professor

Study Record Dates

• First Submitted: June 11, 2019
• First Posted: June 13, 2019
• Study Start: November 1, 2020
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)