drugset / Trial / NCT04062760

Safety and Efficacy of Early, seQUential Oral dIuretic Nephron blockAde In Acute Heart Failure

NCT04062760

RandomizedParallel-groupOpen-labelTreatment

Summary

The SEEQUOIA-AHF (Safety and Efficacy of Early, seQUential oral dIuretic nephron blockAde in Acute Heart Failure) trial is a multicenter, randomized, open-label, parallel-arm trial assessing the impact of early sequential nephron blockade (i.e. a regimen based on the combination of four oral diuretics with different sites of action along the nephron at low doses) compared to a conventional approach with a high-dose loop diuretic in the treatment of congestion in patients hospitalized with acute heart failure (AHF). In this study, after 24-72 hours of high-dose intravenous furosemide started at the time of hospital admission, patients admitted with AHF will be randomized to open-label oral treatment with either low-dose sequential nephron blockade or high-dose furosemide for 96 hours. The primary end-point will be the bivariate change in body weight and serum creatinine value at 96 hours since randomization. Secondary endpoints will include clinical (e.g., total change in body weight during hospitalization, change in dyspnea score at 96 hours since randomization, 30-day readmission rate) and laboratory (e.g., change in BNP or NT-proBNP at discharge vs randomization) parameters, and safety (e.g., change in serum creatinine value at discharge versus randomization and up to 30 days from discharge) issues.

Timeline

Start
2019-12-01
Primary completion
2021-12-01
Completion
2024-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetazolamide Small molecule Oral
Comparator Furosemide Other / unclassified Oral
Subject Metolazone Small molecule Oral
Background Canrenoate Small molecule Oral
Background Spironolactone Small molecule Oral

Indications