Heart Failure Acute Clinical Trial
— DANAUS-AHFOfficial title:
Diuretic and Natriuretic Effect of High-dose Spironolactone in Patients With Acute Heart Failure
Verified date | November 2020 |
Source | Laik? General Hospital, Athens |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | March 1, 2022 |
Est. primary completion date | December 20, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Greece | Laiko General Hospital | Athens | Attiki |
Lead Sponsor | Collaborator |
---|---|
Laik? General Hospital, Athens |
Greece,
Kapelios CJ, Bonou M, Vogiatzi P, Tzanis G, Mantzouratou P, Lund LH, Barbetseas J. Association Between High-Dose Spironolactone and Decongestion in Patients with Acute Heart Failure: An Observational Retrospective Study. Am J Cardiovasc Drugs. 2018 Oct;18(5):415-422. doi: 10.1007/s40256-018-0290-3. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Daily urine output | Urine output in liters per 24 hours will be tracked from enrollment to day 5. | 5 days | |
Secondary | Total urine output | Urine output in total liters from enrollment to day 5 will be measured. | 5 days | |
Secondary | Total weight change | Patient weight in kilos will be tracked from enrollment to day 5. | 5 days | |
Secondary | Daily weight change | Patient weight in kilos will be tracked from enrollment to day 5. | 5 days | |
Secondary | Natriuresis on days 1, 3 and 5 | Urine sodium will be measured on days 1, 3 and 5 | 5 days | |
Secondary | Changes in natriuresis between days 1, 3 and 5 | Urine sodium will be measured on days 1, 3 and 5 | 5 days | |
Secondary | Changes in NT-proBNP between days 1 and 5 | NT-proBNP will be measured on days 1, 3 and 5 | 5 days |
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