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

NCT ID: NCT04367051

Last Updated: 2023-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-13
• Study Completion Date: 2022-06-30

Brief 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

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Withdrawal group

Spironolactone will be discontinued in patients who were receiving optimal medical therapy including angiotensin-converting enzyme or angiotensin receptor blocker or angiotensin receptor neprilysin, beta-blocker, and spironolactone.

Group Type: EXPERIMENTAL

Withdrawal of Spironolactone

Intervention Type: DRUG

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

Continuation group

Spironolactone will be continued during the study period with other medical therapy in combination.

Group Type: ACTIVE_COMPARATOR

Continuation of spironolactone

Intervention Type: DRUG

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.

Interventions

Withdrawal of Spironolactone

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Willing and capable of providing informed consent and agrees to follow the study protocol and schedule of clinical follow-up
• Age between 19 and 80 years old
• Prior diagnosis of heart failure with reduced left ventricular ejection fraction (LV EF ≤ 35%) and on medical therapy including spironolactone combined with angiotensin-converting enzyme or angiotensin receptor blocker or antiotensin receptior neprilysin blocker, beta-blocker.
• LV EF ≥ 50% documented with echocardiography performed within a month
• Documented result of BNP or NT-proBNP level within a month

Exclusion Criteria

• Dyspnea ≥ New York Heart Association (NYHA) functional class III
• Patients who need to discontinue spironolactone owing to prior adverse event
• Primary valvular heart disease with at least moderate degree
• Estimated glomerular filtration rate less than 30 mL/min per 1.73 m2
• Uncontrolled hypertension defined as blood pressure more than 140/90 mmHg
• Presence of other clinical reason to continue spironolactone such as myocardial infarction, primary aldosteronism, and liver cirrhosis
• Hyperkalemia defined as serum potassium level less than 3.5 mmol per liter
• Pregnant and/or lactating women
• Life expectancy less than a year
• Patients who are not suitable to enrollment by investigator's discretion

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Sang Eun Lee

professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Asan Medical Center

Seoul, Songpa-gu, South Korea

Countries

South Korea

References

Hyun J, Lee SA, Lee SE, Hong JA, Kim MS, Kim JJ. Withdrawal of Spironolactone for Heart Failure With Improved Ejection Fraction: An Open-Label, Pilot, Randomized Controlled Trial (With-HF Trial). Korean Circ J. 2025 Jul 8. doi: 10.4070/kcj.2025.0052. Online ahead of print.

Reference Type: DERIVED

PMID: 40736394 (View on PubMed)

Other Identifiers

AMC_2020_0613

Identifier Type: -

Identifier Source: org_study_id