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IRCT20250919067292N1 IRCT 2025-12-14 Tehran University of Medical Sciences Acetazolamide in edema in patients with Heart Failure Evaluating the Efficacy of Oral Acetazolamide in Edema in Patients with Acute Decompensated Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial 2025-12-22 anticipated 90 Recruiting https://irct.ir/trial/86263 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be based on a 1:1 ratio to receive acetazolamide or placebo. The randomization list is generated using the block randomization method in 9 blocks of 10 by an online random number generator (www.sealedenvelop.com). Then, an independent pharmacist of the study will pack acetazolamide and placebo in sealed and numbered envelopes based on the randomized list. The contents of the envelopes will be indistinguishable. The pharmacist evaluating the outcome will deliver the envelopes containing the drug or placebo to a nurse based on the randomization list to be given to the patients, Blinding description: Placebo with the same shape, size, color, smell, and appearance as acetazolamide medication will be placed in sealed envelopes based on a randomization list generated by an independent pharmacist. The pharmacist evaluating outcome will be unaware of the contents of the envelopes and will deliver them to the nurses. Therefore, the study will be double-blinded, and the study participants and outcome assessor will be blinded to the study. 3 Acute decompensated heart failure. Intervention 1: Intervention group:‪ They will receive acetazolamide 500 mg on day zero, then 250 mg twice daily for three days.‬. Intervention 2: Control group: ‪They will receive placebo equivalent to acetazolamide tablets in the intervention group on day zero and twice a day for three days.‬ A placebo tablet with a similar appearance to acetazolamide 250 mg tablets (round white tablets), based on the registered formulation of acetazolamide tablets and similar excipients, without the active ingredient, has been designed and manufactured by Banyan Salamat Kasra (BSK) company. Yes - There is a plan to make this available What will be shared: The patient characteristic data such as age, gender, and medications used, as well as information related to the primary and secondary outcomes of the intervention after de-identifying individuals. When: The beginning of access is after the conclusion of trial and the publication of results To whom: Access permission to academic and hospital researchers Conditions: Statistical analysis Where to obtain: 1- Dr. Fatemeh Matinfarid fatemeh7.m.f80@gmail.com 2. Dr. Keyhan Mohammadi keyhanmohammadi72@yahoo.com 3. Dr SOmaye Mohammadi somayemohammadi.sm۶۱@gmail.com How to obtain: First, the applicant must send the documents they request access to, along with the reason and details, via email to the researchers of this project (provided in the previous box). After review and consultation, these documents will be sent to them. Comments:
public Somaye Mohammadi
Cardiac care unit, Imam Khomeini Hospital, East Bagherkhan Street, East Chamran Highway
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6619 0000 somayemohammadi.sm۶۱@gmail.com Tehran University of Medical Sciences scientific Keyhan Mohammadi
Pharmaceutical Care Center, Valiasr department, Imam Khomeini Hospital, East Bagherkhan Street, East Chamran Highway
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6658 1692 keyhanmohammadi72@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Informed consent to participate in the study Age over 18 years Diagnosis of ADHF with at least one sign of congestion (such as edema, evidence of abdominal ascites on ultrasound, evidence of pulmonary edema on chest radiography or chest ultrasound) Maintenance therapy with an oral loop diuretic, at least 20 mg furosemide or 10 mg torsemide, one month prior to hospitalization Use of SGLT2i, including dapagliflozin and empagliflozin, for at least one month prior to hospitalization NT-proBNP more than 1000 ng/mL or BNP more than 250 ng/mL 18 years no limit Both Hospitalized due to Acute Coronary Syndrome History of congenital heart disease that requires surgery Systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg despite vasopressor administration Estimated glomerular filtration rate less than 20 mL/min/1.73m² Use of acetazolamide during hospitalization or prior to study entry Use of diuretic medications except for mineralocorticoid antagonists such as spironolactone and eplerenone and loop diuretics such as furosemide Pregnant or breastfeeding women Hyperchloremic metabolic acidosis I50.4 Combined systolic (congestive) and diastolic (congestive) heart failure Treatment - Drugs Placebo Intervention group:‪ They will receive acetazolamide 500 mg on day zero, then 250 mg twice daily for three days.‬ Control group: ‪They will receive placebo equivalent to acetazolamide tablets in the intervention group on day zero and twice a day for three days.‬ A placebo tablet with a similar appearance to acetazolamide 250 mg tablets (round white tablets), based on the registered formulation of acetazolamide tablets and similar excipients, without the active ingredient, has been designed and manufactured by Banyan Salamat Kasra (BSK) company. ‪Decongestion and edema resolustion. Timepoint: Day zero at the beginning then daily for three days after randomization. Method of measurement: Clinical examination and recording congestion score. Tehran University of Medical Sciences Approved 2025-09-16 The Institute Of Pharmaceutical Sciences, Tehran University Of Medical Sciences Second Floor, The Institute Of Pharmaceutical Sciences, Tehran University Of Medical Sciences, 16 Azar Street, Enghelab Square Tehran Tehran Iran (Islamic Republic of)