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

NCT04367051 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2023-10-05

No results posted yet for this study

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

DRUG

Withdrawal of Spironolactone

Other recommended medications for heart failure than spironolactone will be continued for withdrawal group.

DRUG

Continuation of spironolactone

Specific 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.

Sponsors & Collaborators

  • Asan Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-13
Primary Completion
2021-12-10
Completion
2022-06-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04367051 on ClinicalTrials.gov