Efficacy of Oral Acetazolamide in Decongestion in Patients With Heart Failure

Sponsor
Tehran University of Medical Sciences
Study ID
NCT05940220
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acetazolamide — OTHER
    Acetazolamide placebo add-on a standard therapy of iv furosemide in one day and oral furosemide during three consecutive days will be used for the comparator arm
  • placebo — OTHER
    placebo

Study Details

This is a 1:1 ratio single-center, double-blind, randomized controlled trial, aiming to enroll 130 patients admitted in infusion ward. The participants receive furosemide as standard treatment and will randomize towards 250 mg oral acetazolamide twice a day versus placebo on three consecutive days. The main objective is to determine the effect of oral acetazolamide and furosemide combination therapy on the decongestion. Prespecified secondary objectives included N-terminal pro B-type natriuretic peptide level on the 30th day, the readmission rate in a three-month period, quality of life assessment by Heart Failure Quality of Life Questionnaire at the end of the third month, change in weight, creatinine level, urinary sodium excretion, potassium level, and hematological indices in complete blood count at third day of the trial.

Key Dates

Start date
Dec 30, 2023
Status verified
Jun 2023
Primary completion
Jun 30, 2025
Completion
Oct 10, 2025

Study Design

Enrollment
130 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: acetazolamid
    We will administer injectable and oral furosemide in infusion ward based on the dosage determined by the specialist on day zero. After that, we continue oral furosemide administration for three days. The prescribed dose of injectable and oral furosemide is determined by the specialist based on previous visits and hospitalizations in such a way that the patient has the least symptoms. The intervention group will receive acetazolamide 500 mg on day zero, then 250 mg bd for two days and 250 mg on the third day. The control group will receive placebo equivalent to acetazolamide.
  • Placebo Comparator: placebo
    Acetazolamide placebo add-on a standard therapy of iv furosemide in one day and oral furosemide during three consecutive days will be used for the comparator arm.

Primary Outcome Measure

Na/cr Ratio [ Time Frame: baseline and third day ]

Central Contacts

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