Combination Oral Acetazolamide and Intravenous Furosemide on Acute Decompensated Heart Failure Outcomes (COAF-HF)

October 20, 2024 updated by: Ilham Uddin, MD, Universitas Diponegoro

Effects of Combination Oral Acetazolamide and Intravenous Furosemide on Acute Decompensated Heart Failure

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double blind study with 2 treatment groups. Participants diagnosed with ADHF who meet the inclusion criteria and no exclusion criteria are given an explanation regarding the research and additional therapy that will be given, then informed consent is requested. Participants will be randomized to one of the two treatment groups by chance. Patients randomized to the first group will receive intravenous furosemide and oral acetazolamide. Patients randomized to the other treatment group will receive a combination of iv furosemide and placebo. It is expected that the patients of the treatment group with the combination therapy will have a faster reduction of their fluid overload. In consequence the treatment duration and total dose of diuretics administered will be shorter.

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Indonesia
    • Central Java
      • Semarang, Central Java, Indonesia, 50244
        • Recruiting
        • Kariadi Central General Hospital
        • Contact:
      • Semarang, Central Java, Indonesia, 50244
        • Recruiting
        • Department of Cardiology and Vascular Medicine, Universitas Diponegoro, Kariadi Central General Hospital
        • Contact:
        • Principal Investigator:
          • Ilham Uddin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A (Oral Acetazolamide)
Participants who received intravenous furosemide plus acetazolamide 250 mg / 12 hours orally for up to 3 days.
Drug: Oral Acetazolamide
Participants will be randomized into group receiving either oral acetazolamide or placebo for up to 3 days
Other Names:
  • Glauseta
Placebo Comparator: Group B (Placebo)
Participants who received intravenous furosemide plus Placebo / 12 hours orally for up to 3 days.
Drug: Placebo
Participants will be randomized into group receiving either oral acetazolamide or placebo for up to 3 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful Decongestion
Time Frame: within 3 days
Conditions without volume overload, no signs of excess volume within 3 days of treatment. Congestion was assessed using the volume assessment score (also called congestion score) from the ADVOR trial. The absence of fluid volume excess was defined as no more than mild edema, no residual pleural effusion, and no residual ascites. Total score ≤1 indicates that decongestion has been achieved, score >1 is considered to indicate persistent fluid volume excess (decongestion not achieved).
within 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NT pro BNP
Time Frame: within 3 days
the effect of adding combination oral acetazolamide on NT pro BNP levels in ADHF participants who received iv furosemide
within 3 days
Renal Function
Time Frame: From date of randomization until the date of first documented worsening renal function (increased of creatinine serum level >50% of baseline creatinine) or date of death from any cause, evaluation every 48 hours or whichever came first, up to 90 days
Kidney function is measured based on estimated GFR (eGFR) according to the CKD-EPI formula which is shown in units of mL/min/1.73 m2 taken on day 0, day 2, and day 4, every 48 hours during hospitalization (after receiving treatment).
From date of randomization until the date of first documented worsening renal function (increased of creatinine serum level >50% of baseline creatinine) or date of death from any cause, evaluation every 48 hours or whichever came first, up to 90 days
Urinary Output
Time Frame: From date of randomization until participants discharge from hospital up to 7 days post discharge.
the amount of urine for 24 hours is measured from the time the patient arrives at the emergency room, a urinary catheter tube is installed, measured every 24 hours during hospital treatment.
From date of randomization until participants discharge from hospital up to 7 days post discharge.
Length of Stay
Time Frame: From date of randomization until the date of first documented progression and discharge from hospital or date of death from any cause, whichever came first, assessed up to 30 days.
Defined as the duration of the patient receiving treatment in hospital from the time admitted to the ER until the patient was discharged/discharged from the hospital, obtained as the date of discharge from the hospital minus the sampling date +1.
From date of randomization until the date of first documented progression and discharge from hospital or date of death from any cause, whichever came first, assessed up to 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Diponegoro

Investigators

  • Principal Investigator: Ilham Uddin, MD, Department Cardiology and Vascular Medicine Universitas Diponegoro Kariadi General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

June 19, 2024

First Submitted That Met QC Criteria

June 25, 2024

First Posted (Actual)

June 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 20, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No16129/EC/KEPK-RSDK/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Currently, the decision regarding which Individual Participant Data (IPD) will be included for sharing is still under consideration. This undecided status is due to several key factors that require thorough evaluation

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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