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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

Study acronym: CROWD-ASPECT
StatusEnrolling by Invitation
PhasePhase 4
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Dec 2024 to Dec 31, 2028
    • Study completion date: Dec 2026 to Dec 31, 2028
    v4
  2. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Primary completion date: Dec 2023 to Dec 2024
    • Study completion date: Dec 2024 to Dec 2026
    • Start date changed from estimate of Oct 2020 to Nov 1, 2020
    v3
  3. Start date: Jan 2020 to Oct 2020v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Bispebjerg Hospital
48 trials monitored
See 2 trials at risk
Heart Disease
8,786 trials monitored
See 412 trials at risk
Heart Failure
1,995 trials monitored
See 111 trials at risk
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.
Trial Details
NCT Number NCT03984591
Lead Sponsor Bispebjerg Hospital
Collaborators: Rigshospitalet, Denmark
Conditions
(from sponsor)		 Systolic Heart Failure
Related terms Heart Failure, Systolic
Enrollment 7,200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov