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Completed

NCT Number: NCT04367051

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

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.

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Key information

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center

Seoul, Songpa-gu, 138-736, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Withdrawal of Spironolactone

Drug

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

Continuation of spironolactone

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.

Primary outcomes

  1. Change of left ventricular ejection fraction

    Time frame: 6 month

    Proportion of patients with change of left ventricular ejection fraction declining more than 10%

Secondary outcomes

  1. Numerical change of left ventricular ejection fraction

    Time frame: 6 month

    Comparison as continuous variable

  2. Change of serum level on B-type natriuretic peptide or N-terminal pro-brain natriuretic peptide

    Time frame: 6 months

    Each serum level transformed with a log value and comparing with baseline level

  3. Change of serum level of biomarkers (e.g. soluble ST-2, galectin-3)

    Time frame: 6 months

    Serum biomarkers such as soluble ST-2, galectin-3 are checked and compared with baseline value for prediction of decreased left ventricular ejection fraction

  4. Rates of death, re-hospitalization or visit on emergency department for heart failure

    Time frame: 6 months

    Adverse clinical events

  5. results of each outcomes during extended follow-up period

    Time frame: 2 years

    change of echocardiographic parameters, clinical events, natriuretic peptide

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 29, 2020
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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