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

NCT06475105 | Recruiting Phase 4 DMC

• 1 other identifier: No16129/EC/KEPK-RSDK/2024
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Decompensated Heart Failure

Keywords

Oral Acetazolamide; Acute Decompensated Heart Failure; Congestion

Outcome Measures

Primary Outcomes (1)

• Successful Decongestion

  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 Outcomes (4)

• NT pro BNP

  within 3 days

• Renal Function

  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

  From date of randomization until participants discharge from hospital up to 7 days post discharge.

• Length of Stay

  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.

Study Arms (2)

Group A (Oral Acetazolamide)

EXPERIMENTAL

Participants who received intravenous furosemide plus acetazolamide 250 mg / 12 hours orally for up to 3 days.

Drug: Oral Acetazolamide

Group B (Placebo)

PLACEBO COMPARATOR

Participants who received intravenous furosemide plus Placebo / 12 hours orally for up to 3 days.

Drug: Placebo

Interventions

Oral Acetazolamide DRUG

Participants will be randomized into group receiving either oral acetazolamide or placebo for up to 3 days

Also known as: Glauseta

Group A (Oral Acetazolamide)

Placebo DRUG

Participants will be randomized into group receiving either oral acetazolamide or placebo for up to 3 days

Group B (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitas Diponegoro: lead

Study Sites (2)

Department of Cardiology and Vascular Medicine, Universitas Diponegoro, Kariadi Central General Hospital

Semarang, Central Java, 50244, Indonesia

RECRUITING

Kariadi Central General Hospital

Semarang, Central Java, 50244, Indonesia

RECRUITING

MeSH Terms

Interventions

Acetazolamide

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Ilham Uddin, MD

  Department Cardiology and Vascular Medicine Universitas Diponegoro Kariadi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inne P Farissa, MD

CONTACT

024-8413476; innefarissa@gmail.com

Tahari B Prakoso, MD

CONTACT

024-8413476; ibas_tbargasp@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FAsCC, FSCAI

Model Details: This research is an experimental clinical study with a double blinded randomized controlled trial design. The study group consisted of patients with acute decompensated heart failure with volume overload who required intravenous diuretic therapy. The first group was patients who received intravenous furosemide plus acetazolamide 250 mg / 12 hours orally for up to 3 days (group A). Meanwhile, the second group was patients who received intravenous furosemide plus placebo for up to 3 days (group B).

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 26, 2024
• Study Start: April 20, 2024
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)