?Effect of amilodipine on heart function and cardiac iron deposition in ß-thalassemia patients
Phase 2
- Conditions
- ß-thalassemia.Beta thalassemiaD56.1
- Registration Number
- IRCT20090613002027N15
- Lead Sponsor
- Sari University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 62
Inclusion Criteria
Beta-thalassemia patients with moderate to severe heart sediment (MRI based on a less than 15 milliseconds)
Age over 18 years
Written informed consent
Exclusion Criteria
Use of other calcium channel blockers (verapamil-diltiazem-carvedilol)
Continuous hypotension due to heart failure severity
Aortic valve stenosis
Sinoatrial node diseas
Heart failure
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cardiac MRI T2. Timepoint: Baseline, month 6 and month 12. Method of measurement: Performing MRI T2.;Left Ventricular End Diastolic Diameter (LVEDD). Timepoint: Baseline, month 6 and month 12. Method of measurement: Echoardiography.;Left Ventricular End Systolic Diameter (LVESD). Timepoint: Baseline, month 6 and month 12. Method of measurement: Ecocardiography.
- Secondary Outcome Measures
Name Time Method Ferritin. Timepoint: Baseline, month 6 and month 12. Method of measurement: Kit of ferritin assay.