Using oral acetazolamide with intravenous furosemide to treat heart failure
Effects of Combination Oral Acetazolamide and Intravenous Furosemide on Acute Decompensated Heart Failure
This study is testing if taking acetazolamide with furosemide can help people with acute heart failure feel better by improving fluid removal from their bodies.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitas Diponegoro Academic / other |
| Locations | 2 sites (Semarang, Central Java and 1 other locations) |
| Trial ID | NCT06475105 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of combining oral acetazolamide with intravenous furosemide in patients suffering from acute decompensated heart failure. It is a randomized, double-blind study where participants will be assigned to receive either the combination therapy or a placebo alongside furosemide. The primary goal is to assess whether this combination leads to improved decongestion, as measured by urinary output and changes in NT-proBNP levels. The study is being conducted in a single hospital in Indonesia, focusing on patients with specific criteria related to heart failure symptoms.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with acute decompensated heart failure who exhibit signs of fluid overload and are on loop diuretic therapy.
Not a fit: Patients with acute coronary syndrome, severe renal impairment, or those requiring renal replacement therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective treatment options for patients with acute decompensated heart failure.
How similar studies have performed: Previous studies have shown promise with similar approaches, but this specific combination is being tested in a novel context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Use of renal replacement therapy or ultrafiltration at any time before the study was included. * Treatment with acetazolamide within 1 month before randomization. * Exposure to nephrotoxic agents (i.e. contrast dye) is anticipated within the next 3 days * Subjects who are pregnant or breastfeeding. * Subjects with urinary incontinence who are unwilling to use a bladder catheter.
Where this trial is running
Semarang, Central Java and 1 other locations
- Department of Cardiology and Vascular Medicine, Universitas Diponegoro, Kariadi Central General Hospital — Semarang, Central Java, Indonesia (Recruiting)
- Kariadi Central General Hospital — Semarang, Central Java, Indonesia (Recruiting)
Study contacts
- Principal investigator: Ilham Uddin, MD — Department Cardiology and Vascular Medicine Universitas Diponegoro Kariadi General Hospital
- Study coordinator: Inne P Farissa, MD
- Email: innefarissa@gmail.com
- Phone: 024-8413476
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.