A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure
NCT ID: NCT03984591
Last Updated: 2023-02-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ENROLLING_BY_INVITATION
PHASE4
7200 participants
INTERVENTIONAL
2020-11-01
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Spironolactone in the Treatment of Heart Failure
NCT04727073
Study of High-dose Spironolactone vs. Placebo Therapy in Acute Heart Failure
NCT02235077
The Effect of Amiloride and Spironolactone in Patients With Hypertension
NCT01388088
Aldosterone Blockade in Heart Failure
NCT00523757
The Effect of Amiloride and Spironolactone in Healthy Persons
NCT00857909
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Spironolactone
Spironolactone used according to heart failure guidelines
Spironolactone
Spironolactone according to guidelines
Eplerenone
Eplerenone used according to heart failure guidelines
Eplerenone
Eplerenone according to guidelines
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Eplerenone
Eplerenone according to guidelines
Spironolactone
Spironolactone according to guidelines
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rigshospitalet, Denmark
OTHER
Bispebjerg Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jens Jakob Thune
Clinical research associate professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jens Jakob Thune, MD, PhD
Role: STUDY_CHAIR
Copenhagen University Hospital - Bispebjerg and Frederiksberg, Copenhagen, Denmark
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Bispebjerg Hospital
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CROWD-ASPECT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.