Evaluation of Heart Status in Patients of Beta Thalassemia Using Echocardiogram
Sponsor
Nanfang Hospital of Southern Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04929574
Collaborator
ZhuHai Hospital (Other), Shenzhen Children's Hospital (Other), Shenzhen Second People's Hospital (Other), Jiangmen Maternity and Child Health Care Hospital (Other), Yongzhou Maternity and Child Health Hospital (Other)
1,200
1
54
22.2
Study Details
Study Description
Brief Summary
Heart failure from myocardial iron deposition is a severe complication for patients with transfusion-dependent beta thalassemia . Increased cardiac iron content impacts the contractility of cardiomyocytes and can also lead to myocarditis, pericarditis, and arrhythmias. The severity of cardiac dysfunction depends on the amount of iron deposited in the myocardium.Echocardiogram is used as noninvasive method to observe heart status. The objective of this study is to evaluate the heart status in patients of Beta Thalassemia from southern China.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
1200 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Evaluation of Heart Status in Patients of Beta Thalassemia Using Echocardiogram
Anticipated Study Start Date
:
Jul 1, 2021
Anticipated Primary Completion Date
:
Jul 1, 2024
Anticipated Study Completion Date
:
Dec 30, 2025
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| beta thalassemia patients
|
Diagnostic Test: Echocardiogram and Hematological Analysis
Echocardiogram and Hematological Analysis
|
Outcome Measures
Primary Outcome Measures
- Echocardiogram [3 years]
Evaluation of heart function in beta thalassemia patients by left ventricular fraction shortening
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
- Diagnosed with beta-thalassemia
Exclusion Criteria:
- Iron deficiency anemia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southern Medical University | Guangzhou | Guangdong | China | 510515 |
Sponsors and Collaborators
- Nanfang Hospital of Southern Medical University
- ZhuHai Hospital
- Shenzhen Children's Hospital
- Shenzhen Second People's Hospital
- Jiangmen Maternity and Child Health Care Hospital
- Yongzhou Maternity and Child Health Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT04929574
Other Study ID Numbers:
- Heart-Beta thalassemia
First Posted:
Jun 18, 2021
Last Update Posted:
Jun 18, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: