Diuretic and Natriuretic Effect of High-dose Spironolactone in Patients With Acute Heart Failure (NCT04618601) | Clinical Trial Compass
UnknownPhase 4
Diuretic and Natriuretic Effect of High-dose Spironolactone in Patients With Acute Heart Failure
Greece50 participantsStarted 2020-10-20
Plain-language summary
This is a prospective, single-center, open-label and randomized trial for evaluation of the effect of a 5-day administration of high doses of spironolactone (≥100mg daily) on diuresis, natriuresis, weight loss and levels of NT-proBNP in hospitalized patients with acute decompensated heart failure (ADHF). Mineralocorticoid receptor antagonists (MRAs) are recommended as standard of care (SOC) in management of heart failure (HF) patients. However, recommended doses of MRAs (up to 50mg daily) have any impact on signs and symptoms of volume overload. Therefore, the proposed study will aim to show the impact of high doses of spironolactone to improve diuresis, natriuresis, weight loss and levels of NT-proBNP in hospitalized patients with ADHF.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of acute heart failure within the past 8 hours
* Two of the following: 1. edema, 2. ascites, 3. jugular vein distention, 4. pulmonary congestion
* NT-proBNP \>1,000 pg/ml or \>3,000 pg/ml (in the presence of atrial fibrillation)
* Per os mean daily loop diuretic dose equivalent to 80 mg of furosemide for at least 1 month prior to presentation and at least one of the following: 1. serum urea/serum creatinine \> 50 at presentation, 2. serum creatinine increased \>0.3 mg/dl compared with previous value (within the last year), 3. serum creatinine \> 1.8 mg/dl.
Exclusion Criteria:
* pregnancy or breast feeding
* current acute coronary syndrome
* significant valvular disease
* pulmonary embolism
* allergy or intolerance to spironolactone
* current mechanical circulatory support
* primary hypertrophic cardiomyopathy, infiltrative cardiomyopathy
* mean arterial pressure \<65mmHg or systolic arterial pressure \<90 mmHg at presentation
* anticipated use of inotropes or vasodilators (other than renal doses of dopamine, i.e. \<2.5 μg/kg/min)
* anticipated need of ultrafiltration
* exposure to nephrotoxic agents within 3 days of presentation
* serum potassium\> 5 mmol/L
* per os receipt of spironolactone or eplerenone in a dose \> 50 mg daily prior to presentation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.