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Trial record 9 of 112 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)

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ClinicalTrials.gov Identifier: NCT03984591
Recruitment Status : Not yet recruiting
First Posted : June 13, 2019
Last Update Posted : June 13, 2019
Sponsor:
Collaborator:
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

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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 : January 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

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Jens Jakob Thune, Clinical research associate professor, Bispebjerg Hospital
ClinicalTrials.gov Identifier: NCT03984591     History of Changes
Other Study ID Numbers: CROWD-ASPECT
First Posted: June 13, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
spironolactone
eplerenone
mortality
Additional relevant MeSH terms:
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Eplerenone
Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases
Spironolactone
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Diuretics, Potassium Sparing
Diuretics
Natriuretic Agents
Antihypertensive Agents