Actively Recruiting
Effects of Combination Oral Acetazolamide and Intravenous Furosemide on Acute Decompensated Heart Failure
Led by Universitas Diponegoro · Updated on 2024-10-22
66
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the addition of oral acetazolamide to intravenous furosemide to treat congestion in patients with Acute Decompensated Heart Failure (ADHF). This study is based on previous findings from the ADVOR trial and aims to see if oral acetazolamide can increase the success of decongestion, increase urine output, affect NT pro BNP levels, and assess the safety of this combination. The trial is conducted in single hospitals in Indonesia where intravenous acetazolamide is unavailable. This is a randomized, double-blind study with two treatment groups. One group receives intravenous furosemide plus oral acetazolamide at a dose of 250 mg every 12 hours for up to three days, while the other group receives intravenous furosemide plus a placebo orally at the same schedule. The study expects that the combination therapy group will experience faster fluid reduction, leading to shorter treatment duration and less total diuretic use. Participants diagnosed with ADHF who meet eligibility criteria will be randomized and monitored for at least three days to evaluate successful decongestion. Researchers will assess urinary output, NT pro BNP levels, renal function, and length of hospital stay up to 30 days. Kidney function will be monitored every 48 hours or as needed for up to 90 days, and urinary output is tracked until discharge and up to seven days after. The study includes safety monitoring and follow-up to evaluate overall treatment effects.
CONDITIONS
Brief 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
- Patients with a clinical diagnosis of acute decompensated heart failure with at least one clinical sign of volume overload and a congestion score of 2 or more
- Patients on routine oral loop diuretic therapy with a dose of 40 mg or more furosemide for at least 1 month
- Plasma NT-proBNP levels increased by 300 pg/mL or more or applicable cut-off according to age at examination in the emergency room
You will not qualify if you...
- Subjects with acute coronary syndrome
- History of congenital heart disease requiring surgical correction
- Subjects in cardiogenic shock
- Estimated glomerular filtration rate less than 20 mL/min/1.73m2 at examination
- Use of renal replacement therapy or ultrafiltration at any time before study inclusion
- Treatment with acetazolamide within 1 month before randomization
- Anticipated exposure to nephrotoxic agents such as contrast dye within next 3 days
- Subjects who are pregnant or breastfeeding
- Subjects with urinary incontinence unwilling to use a bladder catheter
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 days
Participants receive either intravenous furosemide plus oral acetazolamide or intravenous furosemide plus placebo for up to 3 days to reduce fluid overload in acute decompensated heart failure.
Daily visits while hospitalized up to 3 days
Duration - Up to 90 days
Participants are monitored for renal function, urinary output, and length of hospital stay after treatment, with evaluations continuing up to 90 days for renal function and up to 30 days for hospital stay.
Assessments every 48 hours up to 90 days; urinary output monitored up to 7 days post discharge; hospital stay monitored up to 30 days
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
T
Tahari B Prakoso, MD
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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