A Phase 4 interventional study of Oral Acetazolamide and Placebo in Acute Decompensated Heart Failure, sponsored by Universitas Diponegoro. Recruiting at 2 sites in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-22.
Sponsored by Universitas Diponegoro · Phase 4, Interventional, and Treatment
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.
This is a randomized, double blind study with 2 treatment groups. Participants diagnosed with ADHF who meet the inclusion criteria and no exclusion criteria are given an explanation regarding the research and additional therapy that will be given, then informed consent is requested. Participants will be randomized to one of the two treatment groups by chance. Patients randomized to the first group will receive intravenous furosemide and oral acetazolamide. Patients randomized to the other treatment group will receive a combination of iv furosemide and placebo. It is expected that the patients of the treatment group with the combination therapy will have a faster reduction of their fluid overload. In consequence the treatment duration and total dose of diuretics administered will be shorter.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 66 is close to the median of 72 across 3,736 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Universitas Diponegoro is the lead sponsor of 23 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants who received intravenous furosemide plus acetazolamide 250 mg / 12 hours orally for up to 3 days.
Drug: Oral Acetazolamide
Participants who received intravenous furosemide plus Placebo / 12 hours orally for up to 3 days.
Drug: Placebo
Participants will be randomized into group receiving either oral acetazolamide or placebo for up to 3 days
Also known as: Glauseta
Participants will be randomized into group receiving either oral acetazolamide or placebo for up to 3 days
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).
Time frame: within 3 days
NT pro BNP
the effect of adding combination oral acetazolamide on NT pro BNP levels in ADHF participants who received iv furosemide
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Plan to share: No — Currently, the decision regarding which Individual Participant Data (IPD) will be included for sharing is still under consideration. This undecided status is due to several key factors that require thorough evaluation
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Universitas Diponegoro