Combination Oral Acetazolamide and Intravenous Furosemide on Acute Decompensated Heart Failure Outcomes
NCT Number: NCT06475105
Acronym: COAF-HF
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Acute Decompensated Heart Failure
Interventions: DRUG: Oral Acetazolamide|DRUG: Placebo
Sponsor: Universitas Diponegoro
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 66
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-04-20
Completion Date: 2024-08-01
Locations: Department of Cardiology and Vascular Medicine, Universitas Diponegoro, Kariadi Central General Hospital, Semarang, Central Java, 50244, Indonesia|Kariadi Central General Hospital, Semarang, Central Java, 50244, Indonesia

Summary:
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.

Primary Outcome Measures: 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)., within 3 days
Secondary Outcome Measures: NT pro BNP, the effect of adding combination oral acetazolamide on NT pro BNP levels in ADHF participants who received iv furosemide, within 3 days|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)., From date of randomization until the date of first documented worsening renal function (increased of creatinine serum level >50% of baseline creatinine) or date of death from any cause, evaluation every 48 hours or whichever came first, up to 90 days|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., From date of randomization until participants discharge from hospital up to 7 days post discharge.|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., From date of randomization until the date of first documented progression and discharge from hospital or date of death from any cause, whichever came first, assessed up to 30 days.