Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Status:
Not yet recruiting
Trial end date:
2027-03-31
Target enrollment:
Participant gender:
Summary
Aim to identify the best strategy for treating acute heart failure (AHF) with volume
overload, particularly focusing on patients resistant to standard loop-diuretics. The trial
is a double-blinded, randomized, controlled, multicenter study. Its primary objective is to
compare the efficacy of loop-diuretics combined with either Metolazone or Acetazolamide,
against loop-diuretics alone. The trial will also determine the optimal type of loop-diuretic
to use.
Eligible participants include adults over 18 years hospitalized with AHF and volume overload,
showing signs of congestion and at risk of diuretic resistance. Exclusions apply to those
with acute coronary syndrome, low systolic blood pressure, prior renal therapy, or previous
treatment with Acetazolamide or Metolazone.
The primary outcome is the number of days alive and out-of-hospital by day 30. Secondary
outcomes include a composite clinical benefit at 30 days, Kansas City Cardiomyopathy
Questionnaire (KCCQ) scores, and successful decongestion 72 hours post-inclusion.
The trial aims to enroll about 1,041,939 patients across three treatment arms over three
years. The minimal important difference is set as a reduction in out-of-hospital days by at
least two days, with an anticipated low dropout rate. The study's power is calculated to be
80% with an adjusted alpha level for comparing the three diuretic groups.