COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu
Trial record 9 of 120 for:    EPLERENONE

A 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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03984591
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : July 8, 2020
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Jens Jakob Thune, Bispebjerg Hospital

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.

Condition or disease Intervention/treatment Phase
Systolic Heart Failure Drug: Eplerenone Drug: Spironolactone Phase 4

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 7200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cluster and Registry Trials Of the Working Group of Heart Failure in Denmark: Are SPironolactone and Eplerenone Comparable Treatments?
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Spironolactone
Spironolactone used according to heart failure guidelines
Drug: Spironolactone
Spironolactone according to guidelines

Active Comparator: Eplerenone
Eplerenone used according to heart failure guidelines
Drug: Eplerenone
Eplerenone according to guidelines

Primary Outcome Measures :
  1. Mortality [ Time Frame: 5 years ]
    Mortality (will be used if overall mortality rate is 15% or greater)

  2. Mortality or hospitalization for heart failure [ Time Frame: 6 years ]
    Will be used if overall mortality is less than 15%

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Layout table for additonal information
Responsible Party: Jens Jakob Thune, Clinical research associate professor, Bispebjerg Hospital Identifier: NCT03984591    
Other Study ID Numbers: CROWD-ASPECT
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: July 8, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
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
Keywords provided by Jens Jakob Thune, Bispebjerg Hospital:
aldosterone antagonists
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Natriuretic Agents
Antihypertensive Agents