Back to resultsA Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure (CROWD-ASPECT)
Primary Purpose
Systolic Heart Failure
Status
Enrolling by invitation
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Eplerenone
Spironolactone
Sponsored by
About this trial
This is an interventional treatment trial for Systolic Heart Failure focused on measuring aldosterone antagonists, spironolactone, eplerenone, mortality
Eligibility Criteria
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
Sites / Locations
- Bispebjerg Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Spironolactone
Eplerenone
Arm Description
Spironolactone used according to heart failure guidelines
Eplerenone used according to heart failure guidelines
Outcomes
Primary Outcome Measures
Mortality
Mortality (will be used if overall mortality rate is 15% or greater)
Mortality or hospitalization for heart failure
Will be used if overall mortality is less than 15%
Secondary Outcome Measures
Full Information
NCT ID
NCT03984591
First Posted
June 11, 2019
Last Updated
January 30, 2023
Sponsor
Bispebjerg Hospital
Collaborators
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT03984591
Brief Title
A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure
Acronym
CROWD-ASPECT
Official Title
Cluster and Registry Trials Of the Working Group of Heart Failure in Denmark: Are SPironolactone and Eplerenone Comparable Treatments?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systolic Heart Failure
Keywords
aldosterone antagonists, spironolactone, eplerenone, mortality
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Spironolactone
Arm Type
Active Comparator
Arm Description
Spironolactone used according to heart failure guidelines
Arm Title
Eplerenone
Arm Type
Active Comparator
Arm Description
Eplerenone used according to heart failure guidelines
Intervention Type
Drug
Intervention Name(s)
Eplerenone
Intervention Description
Eplerenone according to guidelines
Intervention Type
Drug
Intervention Name(s)
Spironolactone
Intervention Description
Spironolactone according to guidelines
Primary Outcome Measure Information:
Title
Mortality
Description
Mortality (will be used if overall mortality rate is 15% or greater)
Time Frame
5 years
Title
Mortality or hospitalization for heart failure
Description
Will be used if overall mortality is less than 15%
Time Frame
6 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Jakob Thune, MD, PhD
Organizational Affiliation
Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Data is located on research servers with Statistics Denmark. Individual participant data may not be exported from the servers.
Learn more about this trial
A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure
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