Clinical Trials Directory

Trials / Completed

CompletedNCT04367051

Pilot Study on Withdrawal of Spironolactone Among Heart Failure With Improved Ejection Fraction

Withdrawal of Spironolactone Treatment for Heart Failure With Improved Left Ventricular Ejection Fractraction: an Open-label Randomized Controlled Pilot Study (With-HF Trial)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
62 (actual)
Sponsor
Asan Medical Center · Academic / Other
Sex
All
Age
19 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The study is a randomized controlled pilot trial to evaluate whether withdrawal of spironolactone is safe and associated with re-deterioration of left ventricular function in patients with heart failure with improved ejection fraction. The aim of current trial is to test the hypothesis that withdrawal of spironolactone would not be associated with relapse of significant clinical deterioration of left ventricular systolic function.

Conditions

Interventions

TypeNameDescription
DRUGWithdrawal of SpironolactoneOther recommended medications for heart failure than spironolactone will be continued for withdrawal group.
DRUGContinuation of spironolactoneSpecific dose of spironolactone for continuation group is on each physician's discretion with acceptable range of 12.5 mg - 50 mg once or twice daily.

Timeline

Start date
2020-08-13
Primary completion
2021-12-10
Completion
2022-06-30
First posted
2020-04-29
Last updated
2023-10-05

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT04367051. Inclusion in this directory is not an endorsement.