Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06475105

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Screening

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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

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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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