NCT03984591 (CROWD-ASPECT) is a Phase 4 clinical trial of Eplerenone in Systolic Heart Failure, sponsored by Bispebjerg Hospital.

Who is sponsoring NCT03984591?

NCT03984591 is sponsored by Bispebjerg Hospital.

What drugs are being tested in NCT03984591?

Interventions in NCT03984591: Eplerenone, Spironolactone.

What condition does NCT03984591 study?

NCT03984591 studies Systolic Heart Failure.

Is NCT03984591 still recruiting?

NCT03984591 is currently enrolling by invitation. Last updated 1 February 2023.

Last reviewed 2023-02-01 · How we verify

NCT03984591: CROWD-ASPECT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

ENROLLING BY INVITATION Phase 4 Last updated 1 February 2023

What this trial tests

Phase 4 trial testing Eplerenone in Systolic Heart Failure in 7,200 participants. Enrolling by invitation.

Timeline

1 November 2020

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	Bispebjerg Hospital
Phase	Phase 4
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	7,200
Start date	1 November 2020
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	1 location across Denmark

Drugs / interventions tested

Eplerenone (EPLERENONE) — full drug profile →
Spironolactone (spironolactone) — full drug profile →

Conditions studied

Systolic Heart Failure — all drugs for Systolic Heart Failure →

Sponsor

Bispebjerg Hospital

Who can join

Eligibility, any sex, with Systolic Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Eplerenone

Trials testing the same drug.

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NCT06168994 — Role of Eplerenone in Reducing Recurrence of Atrial Fibrillation in Patient With Structural Heart Disease · Phase 4 · not yet recruiting
NCT05593055 — Mineralocorticoid Receptor, Coronary Microvascular Function, and Cardiac Efficiency in Hypertension · Phase 4 · recruiting

Other recruiting trials for Systolic Heart Failure

Currently open trials in the same condition.

NCT05230732 — Neuromodulation of Inflammation and Endothelial Function · NA · recruiting

Other Bispebjerg Hospital trials

Trials by the same sponsor.

NCT06872060 — The Effects of Glucagon on Renal Regional Blood Flow in Humans Measured by Magnetic Resonance. · NA · not yet recruiting
NCT07373587 — Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy · NA · not yet recruiting
NCT07123558 — Anal Cancer Prevention in High-Risk Categories of Men Who Have Sex With Men · NA · not yet recruiting
NCT07124338 — Preventing Hospital Associated Disability in Older Patients: Individualized Nutrition and Exercise Strategy, a Feasibili · NA · active not recruiting
NCT07096648 — Alert Burden When Monitoring Patients at Home · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03984591 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bispebjerg Hospital
Last refreshed: 1 February 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03984591.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing