Effect of Metoprolol on Thalassemia Cardiomyopathy
Overview[ - collapse ][ - ]
| Purpose | effect of B blocker was first evaluated in patient with cardiomyopathy not induced by ischemia and idiopathic which as the most common causes of cardiomyopathy. Effect of BB on Thalassemia cardiomyopathy was evaluated in this study |
|---|---|
| Condition | B Thalassemia |
| Intervention | Drug: metoprolol Drug: placebo |
| Phase | Phase 2/Phase 3 |
| Sponsor | Shiraz University of Medical Sciences |
| Responsible Party | Shiraz University of Medical Sciences |
| ClinicalTrials.gov Identifier | NCT01863173 |
| First Received | May 18, 2013 |
| Last Updated | May 22, 2013 |
| Last verified | May 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | May 18, 2013 |
|---|---|
| Last Updated Date | May 22, 2013 |
| Start Date | January 2012 |
| Estimated Primary Completion Date | December 2012 |
| Current Primary Outcome Measures |
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| Current Secondary Outcome Measures | patient compliance [Time Frame: 6 months] [Designated as safety issue: Yes]drug complication, |
Descriptive Information[ + expand ][ + ]
| Brief Title | Effect of Metoprolol on Thalassemia Cardiomyopathy |
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| Official Title | The Effect of Metoprolol Succinate on the Cardiac Function of Patients With Thalassemia Cardiomyopathy a Double Blind Randomized Study |
| Brief Summary | effect of B blocker was first evaluated in patient with cardiomyopathy not induced by ischemia and idiopathic which as the most common causes of cardiomyopathy. Effect of BB on Thalassemia cardiomyopathy was evaluated in this study |
| Detailed Description | In this clinical trial, 45 patients with thalassemia cardiomyopathy were randomized to receive either metoprolol (n = 26) or placebo (n = 19). Echocardiography and 6 minute walk test was performed at baseline and repeated after 6 months and the values were compared. |
| Study Type | Interventional |
| Study Phase | Phase 2/Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | B Thalassemia |
| Intervention | Drug: metoprolol using B blocker in patient group Drug: placebo placebo to control group |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 45 |
| Estimated Completion Date | December 2012 |
| Estimated Primary Completion Date | May 2012 |
| Eligibility Criteria | Inclusion Criteria: - documented LVEF < 50% by echocardiography - B thalassemia - No decompensated heart failure for at least 4 weeks (hospitalization for CHF, worsening lower extremity edema, worsening dyspnea on exertion, , and orthopnea) - have no evidence of acute myocarditis and - hemoglobin level above 7 gr⁄dL. Exclusion Criteria: - pulse rate below 60/min - systolic blood pressure less than 90 mmHg - evidence of peripheral vascular disease - major depression, history of asthma, PR interval more than 240 msec, second or third degree AV block - major medical diseases including diabetes mellitus requiring insulin injection, hypothyroidism, hypoparathyroidism, chronic renal failure (glomerular filtration rate below 30 ml/min), hepatic cirrhosis, hepatitis-B and hepatitis-C, positive tests for human immunodeficiency virus, and other hemoglobinopathies |
| Gender | Both |
| Ages | 13 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Iran, Islamic Republic of |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01863173 |
|---|---|
| Other Study ID Numbers | 91-3502 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Shiraz University of Medical Sciences |
| Study Sponsor | Shiraz University of Medical Sciences |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | May 2013 |
Locations[ + expand ][ + ]
| Shiraz University of Medical Sciences | Shiraz, Fars, Iran, Islamic Republic of |
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