Combination Oral Acetazolamide and Intravenous Furosemide on Acute Decompensated Heart Failure Outcomes

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitas Diponegoro

About this trial

Based on ADVOR trial, the potential of adding acetazolamide in increasing the success of decongestion, the amount of natriuresis and diuresis. However, the use of intravenous acetazolamide may not be possible in Indonesia, where the intravenous formulation is not available. This clinical research study is being conducted in single hospitals in Indonesia. We aim to learn if Oral Acetazolamide in addition to Furosemide intravenous works to treat congestion in Acute Decompensated Heart Failure, besides evaluating the total urinary output, change of NT pro BNP level, and safety profile of oral Acetazolamide.

The hypothesis of this study is oral acetazolamide works well to achieve successful decongestion.

Eligibility criteria

Qualifiers

Agree to be included in the research by signing informed consent

Patients with a clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload with a congestion score ≥2 (ADVOR Score) (e.g. edema (score 2 or more), ascites confirmed by physical examination or ultrasonography or pleural effusion confirmed by chest x-ray or echocardiography).

Patients on routine oral loop diuretic therapy with a dose of ≥40 mg furosemide for ≥1 month

Plasma NT-proBNP levels that increase ≥300 pg/mL or the applicable cut-off according to the age range at the time of examination in the ER.

Disqualifiers

Subjects with acute coronary syndrome

History of congenital heart disease requiring surgical correction.

Subjects in cardiogenic shock.

Estimated glomerular filtration rate <20 mL/min/1.73m² at the time of examination.

Trial design

Treatments tested in this trial

  • Oral Acetazolamide
  • Placebo

Treatment groups

66 Participants
are divided into 2 treatment groups

Sponsors and collaborators