Actively Recruiting
Combination Oral Acetazolamide and Intravenous Furosemide on Acute Decompensated Heart Failure Outcomes
Led by Universitas Diponegoro · Updated on 2024-10-22
66
Participants Needed
2
Research Sites
36 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combination Oral Acetazolamide and Intravenous Furosemide on Acute Decompensated Heart Failure Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agree to be included in the research by signing informed consent
- Have a clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload and a congestion score of 2 or higher (ADVOR Score), such as edema (score 2 or more), ascites confirmed by exam or ultrasound, or pleural effusion confirmed by chest x-ray or echocardiography
- Be on routine oral loop diuretic therapy with a dose of 40 mg furosemide or more for at least 1 month
- Have plasma NT-proBNP levels increased by 300 pg/mL or more, or meet the applicable age-based cut-off at the time of examination in the emergency room
You will not qualify if you...
- Have acute coronary syndrome
- Have a history of congenital heart disease requiring surgical correction
- Be in cardiogenic shock
- Have an estimated glomerular filtration rate less than 20 mL/min/1.73m² at the time of examination
- Use renal replacement therapy or ultrafiltration before the study
- Have been treated with acetazolamide within 1 month before randomization
- Expect exposure to nephrotoxic agents (like contrast dye) within the next 3 days
- Be pregnant or breastfeeding
- Have urinary incontinence and are unwilling to use a bladder catheter
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Trial Site Locations
Total: 2 locations
1
Department of Cardiology and Vascular Medicine, Universitas Diponegoro, Kariadi Central General Hospital
Semarang, Central Java, Indonesia, 50244
Actively Recruiting
2
Kariadi Central General Hospital
Semarang, Central Java, Indonesia, 50244
Actively Recruiting
Research Team
I
Inne P Farissa, MD
CONTACT
T
Tahari B Prakoso, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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