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IRCT2015010520563N1 IRCT 2015-08-07 Ahwaz Jundishapur University of Medical Science Effect of Spirnolactone in heart failure Effect of spironolactone with doses 25 and 50 mg in patients with symptomatic Systolic Heart Failure and Ejection Fraction less than 40% on quality of life and Ability and Readmission in 6 months 2014-12-09 anticipated 100 Complete https://irct.ir/trial/18214 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Heart failure. Intervention 1: one group of patients with a daily dose of 25 spironolactone tablets (control)for 6 month and all patients except spironolactone benefited from the same standard treatment for heart failure at discharge. The patients underwent echocardiography at admission with the VIVID 3 by echocardiography fellowship member. EF 2 C and 4 C were measured using SYMPSON. All the para-clinical data (echo, tests, ECG) of the patients were recorded at discharge and quality of life of all patients was assessed and recorded at discharge using Minesutta questionnaire. The questionnaire contained 21 questions, 8 of which concerned physical factors, 5 questions concerned emotional factors and 8 questions concerned other factors. The 21 questions has 105 points and each question and the responses varies from Very Able with 5 scores to Disable with score of zero. Moreover, patients in the rehabilitation ward underwent the 6 MIN walk test. In addition to routine tests and referrals after discharge patients are followed up based on AHA Guidelines in terms of their intention to treat and any incident such as death, not taking medicine, or not tolerating medicine. The telephone number of research team is given to patients and their family so that they call the team in case of any accident in the treatment process, or the need for readmission. As for the condition of electrolytes in spironolactone consumers, patients should be checked 3 and 7 days after the onset of renal function and then they are examined on a monthly basis according to clinical status and history of kidney problems. At the end of week 6 and 6 months electrolytes are checked and recorded. Finally, after 6 months patients undergo echocardiography with VIVID 3 by freshman fellowship and their quality of life was assessed by a questionnaire MINESUTTA. They again undergo 6 MIN walk test. At the end of the study, the percentage change in EF of patients. Intervention 2: group of patients with a daily dose of 50 spironolactone tablets ( case group) for 6 month and all patients except spironolactone benefited from the same standard treatment for heart failure at discharge. The patients underwent echocardiography at admission with the VIVID 3 by echocardiography fellowship member. EF 2 C and 4 C were measured using SYMPSON. All the para-clinical data (echo, tests, ECG) of the patients were recorded at discharge and quality of life of all patients was assessed and recorded at discharge using Minesutta questionnaire. The questionnaire contained 21 questions, 8 of which concerned physical factors, 5 questions concerned emotional factors and 8 questions concerned other factors. The 21 questions has 105 points and each question and the responses varies from Very Able with 5 scores to Disable with score of zero. Moreover, patients in the rehabilitation ward underwent the 6 MIN walk test. In addition to routine tests and referrals after discharge patients are followed up based on AHA Guidelines in terms of their intention to treat and any incident such as death, not taking medicine, or not tolerating medicine. The telephone number of research team is given to patients and their family so that they call the team in case of any accident in the treatment process, or the need for readmission. As for the condition of electrolytes in spironolactone consumers, patients should be checked 3 and 7 days after the onset of renal function and then they are examined on a monthly basis according to clinical status and history of kidney problems. At the end of week 6 and 6 months electrolytes are checked and recorded. Finally, after 6 months patients undergo echocardiography with VIVID 3 by freshman fellowship and their quality of life was assessed by a questionnaire MINESUTTA. They again undergo 6 MIN walk test. At the end of the study, the percentage change in EF of patients.
public Dr Ahmad Reza Asare
Golestan Highway
Ahwaz Iran (Islamic Republic of) +98 61 3222 8037 dr.assareh@gmail.com Ahwaz Jundishapur University of Medical Science scientific Dr Khaled Hamid
Golestan Highway
Ahwaz Iran (Islamic Republic of) +98 61 3222 8037 khaled.hamid93@gmail.com Ahwaz Jundishapur University of Medical Science Iran (Islamic Republic of) Inclusion critria: patient with systolic heart failure ؛ symptomatic ؛ EF<40 EXCLUSION critria: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 women ؛ Significant renal dysfunction (creatinine . 1.8 mg/dL) ؛ Significant hypotension (blood pressure , 90 mmHg systolic and/or ,50 mmHg diastolic ؛ CRT or ICD no limit no limit Both 150.0 congestive heart failure Treatment - Drugs Treatment - Drugs one group of patients with a daily dose of 25 spironolactone tablets (control)for 6 month and all patients except spironolactone benefited from the same standard treatment for heart failure at discharge. The patients underwent echocardiography at admission with the VIVID 3 by echocardiography fellowship member. EF 2 C and 4 C were measured using SYMPSON. All the para-clinical data (echo, tests, ECG) of the patients were recorded at discharge and quality of life of all patients was assessed and recorded at discharge using Minesutta questionnaire. The questionnaire contained 21 questions, 8 of which concerned physical factors, 5 questions concerned emotional factors and 8 questions concerned other factors. The 21 questions has 105 points and each question and the responses varies from Very Able with 5 scores to Disable with score of zero. Moreover, patients in the rehabilitation ward underwent the 6 MIN walk test. In addition to routine tests and referrals after discharge patients are followed up based on AHA Guidelines in terms of their intention to treat and any incident such as death, not taking medicine, or not tolerating medicine. The telephone number of research team is given to patients and their family so that they call the team in case of any accident in the treatment process, or the need for readmission. As for the condition of electrolytes in spironolactone consumers, patients should be checked 3 and 7 days after the onset of renal function and then they are examined on a monthly basis according to clinical status and history of kidney problems. At the end of week 6 and 6 months electrolytes are checked and recorded. Finally, after 6 months patients undergo echocardiography with VIVID 3 by freshman fellowship and their quality of life was assessed by a questionnaire MINESUTTA. They again undergo 6 MIN walk test. At the end of the study, the percentage change in EF of patients group of patients with a daily dose of 50 spironolactone tablets ( case group) for 6 month and all patients except spironolactone benefited from the same standard treatment for heart failure at discharge. The patients underwent echocardiography at admission with the VIVID 3 by echocardiography fellowship member. EF 2 C and 4 C were measured using SYMPSON. All the para-clinical data (echo, tests, ECG) of the patients were recorded at discharge and quality of life of all patients was assessed and recorded at discharge using Minesutta questionnaire. The questionnaire contained 21 questions, 8 of which concerned physical factors, 5 questions concerned emotional factors and 8 questions concerned other factors. The 21 questions has 105 points and each question and the responses varies from Very Able with 5 scores to Disable with score of zero. Moreover, patients in the rehabilitation ward underwent the 6 MIN walk test. In addition to routine tests and referrals after discharge patients are followed up based on AHA Guidelines in terms of their intention to treat and any incident such as death, not taking medicine, or not tolerating medicine. The telephone number of research team is given to patients and their family so that they call the team in case of any accident in the treatment process, or the need for readmission. As for the condition of electrolytes in spironolactone consumers, patients should be checked 3 and 7 days after the onset of renal function and then they are examined on a monthly basis according to clinical status and history of kidney problems. At the end of week 6 and 6 months electrolytes are checked and recorded. Finally, after 6 months patients undergo echocardiography with VIVID 3 by freshman fellowship and their quality of life was assessed by a questionnaire MINESUTTA. They again undergo 6 MIN walk test. At the end of the study, the percentage change in EF of patients Ejection Fraction. Timepoint: At start of study and 6 month later. Method of measurement: Percent. Functional capacity. Timepoint: At start of study and 6 month later. Method of measurement: 6 minute walk test { meter}. Qulity of life. Timepoint: At start of study and 6 month later. Method of measurement: Minesutta Qulity of life qustionare{ score}. Cr. Timepoint: at start. after 3 month. after 6 month. Method of measurement: mg/dL. Potasium. Timepoint: at start. after 3 month. after 6 month. Method of measurement: mg/dL. Hypotansion. Timepoint: at start. after 3 month. after 6 month. Method of measurement: mmHG. Ahwaz Jundishapur University of Medical Science Approved 2015-04-11 Ahwaz Jundishapur University of Medical Science Ahwaz , Golestan Highway Ahwaz Iran (Islamic Republic of)