Safety and Efficacy of Early, seQUential Oral dIuretic Nephron blockAde In Acute Heart Failure
Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 4
Details
Lead Sponsor:
University of Parma
Collaborators:
Azienda Ospedaliero-Universitaria di Parma Azienda Unità Sanitaria Locale Reggio Emilia Azienda USL di Parma