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IRCT20230527058306N1 IRCT 2023-07-08 Tehran University of Medical Sciences Efficacy of Oral Acetazolamide on Decongestion in Patients With Heart Failure Investigating the effect of oral acetazolamide compared to placebo on the severity of heart congestion in patients with heart failure 2023-07-23 anticipated 130 Complete https://irct.ir/trial/70380 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method is used, in which the randomization unit is individual, and random sequence generation software (Random Number Generator software) is used. For concealment, non-transparent sealed envelopes with a random sequence is used . In this method, each random number created is recorded on a card and the cards are placed inside the envelopes in order.In order to maintain the random sequence of the envelopes on the outer surface, the numbering is done in the same order. Finally, the lids of the envelopes are glued and placed in a box. At the time of registration of the participants, based on the order of entry of the eligible participants into the study, one of the envelopes will be opened and the allocated group of that participant will be revealed, Blinding description: To blind the participants, in the control group, instead of acetazolamide, a placebo with the same shape, color, smell and taste as acetazolamide will be given. On the other hand, the outcome evaluator will not know which group received which drug. 3 Chronic congestive heart failure. Intervention 1: Intervention group: They will receive acetazolamide 500 mg tablets in addition to intravenous furosemide on day 0, then 250 mg in addition to oral furosemide on day 2 for two days, and 250 mg acetazolamide plus single dose furosemide on day 3. Intervention 2: Control group: They will receive placebo in addition to intravenous furosemide on day 0, then placebo plus oral furosemide on day 2 for two days, and placebo plus single dose furosemide on day 3. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Houshang Bavandpour karvane
Tehran Heart Center; corner of Jalal El Ahmad Highway; North Kargar St.
Tehran Iran (Islamic Republic of) 13138-14117 +98 21 8802 9600 Houshang.bavandpour20@gmail.com Tehran University of Medical Sciences scientific Houshang Bavandpour karvane
Tehran Heart Center; corner of Jalal El Ahmad Highway; North Kargar St.
Tehran Iran (Islamic Republic of) 6734173113 +98 83 3467 6290 Houshang.bavandpour20@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Earn at least 8 points from EVEREST score Patients over 18 years old The main clinical sign of volume overload includes edema, ascites confirmed by abdominal ultrasound Pleural effusion confirmed by chest X-ray or chest ultrasound without intravenous furosemide Maintenance treatment with oral furosemide as a loop diuretic ≥20 mg for at least one month Using SGLT2i drugs including canagliflozin, dapagliflozin, and empagliflozin for at least one month 18 years 90 years Both Systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg Estimated glomerular filtration rate (eGFR) <20 ml/min/1.73 m2 Using any diuretic agent except mineralocorticoid receptor antagonists including spironolactone and eplerenone Simultaneous diagnosis of acute coronary syndrome, which is characterized by typical chest pain in addition to an increase in troponin level above the 99th percentile or electrocardiographic changes indicating ischemia or hospitalization as unstable angina. I50.42 Chronic combined systolic (congestive) and diastolic (congestive) heart failure Treatment - Drugs Treatment - Drugs Intervention group: They will receive acetazolamide 500 mg tablets in addition to intravenous furosemide on day 0, then 250 mg in addition to oral furosemide on day 2 for two days, and 250 mg acetazolamide plus single dose furosemide on day 3. Control group: They will receive placebo in addition to intravenous furosemide on day 0, then placebo plus oral furosemide on day 2 for two days, and placebo plus single dose furosemide on day 3. Random urine sodium to creatinine ratio. Timepoint: The third day of study. Method of measurement: Urine and blood tests. B-type natriuretic peptide. Timepoint: Thirty days of study. Method of measurement: Blood test. Tehran University of Medical Sciences Approved 2023-05-27 Research Ethics Committees of Tehran Heart Center; Tehran University of Medical Sciences Tehran Heart Center; corner of Jalal El Ahmad Highway; North Kargar St. Tehran Tehran Iran (Islamic Republic of)