drugset / Trial / NCT04618601

Diuretic and Natriuretic Effect of High-dose Spironolactone in Patients With Acute Heart Failure

NCT04618601

Phase 4 Unknown 50 enrolled Laiko General Hospital, Athens
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-10-20
Primary completion
2021-12-20
Completion
2022-03-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Spironolactone Small molecule 100 mg Oral

Indications