NCT06475105 Combination Oral Acetazolamide and Intravenous Furosemide on Acute Decompensated Heart Failure Outcomes
| NCT ID | NCT06475105 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Universitas Diponegoro |
| Condition | Acute Decompensated Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-04-20 |
| Primary Completion | 2024-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 66 participants in total. It began in 2024-04-20 with a primary completion date of 2024-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Ilham Uddin, MD
PRINCIPAL INVESTIGATOR
Department Cardiology and Vascular Medicine Universitas Diponegoro Kariadi General Hospital
Frequently Asked Questions
Who can join the NCT06475105 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Decompensated Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06475105 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06475105 currently recruiting?
Yes, NCT06475105 is actively recruiting participants. Contact the research team at innefarissa@gmail.com for enrollment information.
Where is the NCT06475105 trial being conducted?
This trial is being conducted at Semarang, Indonesia, Semarang, Indonesia.
Who is sponsoring the NCT06475105 clinical trial?
NCT06475105 is sponsored by Universitas Diponegoro. The principal investigator is Ilham Uddin, MD at Department Cardiology and Vascular Medicine Universitas Diponegoro Kariadi General Hospital. The trial plans to enroll 66 participants.
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