Recruiting PHASE4 Acute Decompensated Heart Failure

New treatment option for Acute Decompensated Heart Failure

Official title Combination Oral Acetazolamide and Intravenous Furosemide on Acute Decompensated Heart Failure Outcomes

ClinicalTrials.gov ID: NCT06475105

What this study is testing

What is Oral Acetazolamide?

Oral Acetazolamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute decompensated heart failure.

Also referred to as Glauseta.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 4: studies an already-approved treatment
  • You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • 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...
  • 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.

You likely can't join if

  • people with acute coronary syndrome
  • History of congenital heart disease requiring surgical correction.
  • people 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.
See the full eligibility criteria
Who can join
  • 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...
  • 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.
What rules you out
  • people with acute coronary syndrome
  • History of congenital heart disease requiring surgical correction.
  • people 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
  • people who are pregnant or breastfeeding.
  • people with urinary incontinence who are unwilling to use a bladder catheter.

The study team makes the final eligibility decision.

Where it's taking place

  • Semarang, Central Java, Indonesia

Compensation & support

A stipend or compensation may be offered.

Compensation mentioned.

ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.

Questions & answers

Do participants get paid in this trial?

This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Semarang, Central Java, Indonesia. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.