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IRCT20220404054403N1 IRCT 2022-05-30 Ahvaz University of Medical Sciences Effect of 25 and 100 mg spironolactone on quality of life, ejection fraction and readmission in systolic heart failure patients with reduced ejection fraction Effect of 25 and 100 mg spironolactone on quality of life, ejection fraction and readmission in systolic heart failure patients with reduced ejection fraction in Imam Khomeini hospital in Ahvaz 2022-07-02 anticipated 94 Complete https://irct.ir/trial/62904 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple, individual randomization with table of random numbers. Permuted randomization,Triple blind, Blinding description: Blinding is based on the protocol in in which neither the participants, nor researcher nor the data analyzer knows which treatment or intervention participants are receiving until the clinical trial is over. 3 Systolic heart failure. Intervention 1: Intervention group: 25 mg spironolactone group daily for 6 months. Intervention 2: Intervention group: 100 mg spironolactone group daily for 6 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Hossein Lalvand
Esfand Ave., Golestan Blvd., Ahvaz., Iran
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3222 8037 hosseinlalvand69@gmail.com Ahvaz University of Medical Sciences scientific Hossein Lalvand
Esfand Ave., Golestan Blvd., Ahvaz., Iran
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3222 8037 hosseinlalvand69@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Acute systolic heart failure (EF <40) A history of hospitalization in the last 6 months no limit no limit Both Known contraindications for spironolactone or prior documented intolerance  to an aldosterone receptor antagonist Significant laboratory abnormalities (potassium ≥ 5.1 mmol) Mental disorders suspected to interact with study outcome Pregnant or nursing women Significant renal dysfunction Significant hypotension (lower than 90 mm Hg systolic or 60 mm Hg diastolic) CRT or ICD I50.2 Systolic (congestive) heart failure Treatment - Drugs Treatment - Drugs Intervention group: 25 mg spironolactone group daily for 6 months Intervention group: 100 mg spironolactone group daily for 6 months Ejection fraction. Timepoint: Before the intervention and 6 months after drug administration. Method of measurement: Echocardiography. Quality of life. Timepoint: Before the intervention and 6 months after drug administration. Method of measurement: Minnesota Questionnaire. Readmission. Timepoint: Before the intervention and 6 months after drug administration. Method of measurement: 6 MIN Walk test. Ahvaz University of Medical Sciences Approved 2022-03-08 Ethics committee of Golestan hospital Farvardin Ave., Ahvaz., Iran Ahvaz Khouzestan Iran (Islamic Republic of)