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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Oral Acetazolamide
DrugParticipants will be randomized into group receiving either oral acetazolamide or placebo for up to 3 days
Placebo
DrugParticipants will be randomized into group receiving either oral acetazolamide or placebo for up to 3 days
Treatment groups
Trial outcomes
Primary outcomes
Successful Decongestion
Conditions without volume overload, no signs of excess volume within 3 days of treatment. Congestion was assessed using the volume assessment score (also called congestion score) from the ADVOR trial. The absence of fluid volume excess was defined as no more than mild edema, no residual pleural effusion, and no residual ascites. Total score ≤1 indicates that decongestion has been achieved, score \>1 is considered to indicate persistent fluid volume excess (decongestion not achieved).
Secondary outcomes
NT pro BNP
the effect of adding combination oral acetazolamide on NT pro BNP levels in ADHF participants who received iv furosemide
Renal Function
Kidney function is measured based on estimated GFR (eGFR) according to the CKD-EPI formula which is shown in units of mL/min/1.73 m2 taken on day 0, day 2, and day 4, every 48 hours during hospitalization (after receiving treatment).
Urinary Output
the amount of urine for 24 hours is measured from the time the patient arrives at the emergency room, a urinary catheter tube is installed, measured every 24 hours during hospital treatment.
Length of Stay
Defined as the duration of the patient receiving treatment in hospital from the time admitted to the ER until the patient was discharged/discharged from the hospital, obtained as the date of discharge from the hospital minus the sampling date +1.
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