Beta ThalassemiaNCT04929574
Evaluation of Heart Status in Patients of Beta Thalassemia Using Echocardiogram
An observational study of Beta Thalassemia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Beta Thalassemia
- What is being tested?
- Echocardiogram and Hematological Analysis
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2021to 30 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: beta thalassemia patients from Southern China
Who may be able to join
- Diagnosed with beta-thalassemia
Who cannot join
- Iron deficiency anemia
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Southern Medical University
Guangzhou, Guangdong, 510515
Xiangmin Xu, Prof. Dr., (20) 61648293 ext. 86, xixm@smu.edu.cn
About this study
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.
- Conditions
- Beta Thalassemia
- Being tested
- Echocardiogram and Hematological Analysis
- Medical subject headings
- beta-Thalassemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echocardiogram and Hematological AnalysisDiagnostic test
Echocardiogram and Hematological Analysis
| Study group | Role | What they receive |
|---|---|---|
| beta thalassemia patients | Not described Receives: Diagnostic Test: Echocardiogram and Hematological Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiogram
Evaluation of heart function in beta thalassemia patients by left ventricular fraction shortening
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta ThalassemiaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- ZhuHai Hospital, Shenzhen Children's Hospital, Shenzhen Second People's Hospital, Jiangmen Maternity and Child Health Care Hospital, Yongzhou Maternity and Child Health Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04929574
- Sponsor's protocol ID
- Heart-Beta thalassemia
- Status last verified
- May 2021
- First submitted
- 3 Jun 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Heart Status in Patients of Beta Thalassemia Using Echocardiogram
- ClinicalTrials.gov ID
- NCT04929574
- Acronym / sponsor ID
- Heart-Beta thalassemia
- Conditions
- Beta Thalassemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- ZhuHai Hospital, Shenzhen Children's Hospital, Shenzhen Second People's Hospital, Jiangmen Maternity and Child Health Care Hospital, Yongzhou Maternity and Child Health Hospital
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| beta thalassemia patients | – | Diagnostic Test: Echocardiogram and Hematological Analysis |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- beta thalassemia patients from Southern China
Key inclusion criteria (1 listed)
- Diagnosed with beta-thalassemia
Key exclusion criteria (1 listed)
- Iron deficiency anemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echocardiogram and Hematological AnalysisEchocardiogram and Hematological Analysis | Diagnostic test | beta thalassemia patients |
Primary outcome
Echocardiogram
Time frame: 3 years
Evaluation of heart function in beta thalassemia patients by left ventricular fraction shortening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
Related trials for Beta Thalassemia
Active, not recruiting
Evaluation the Safety and Efficacy of KL003 Cell Injection in the Treatment of Transfusion-dependent β-thalassemia.
Transfusion-dependent Beta-Thalassemia
RecruitingObservational study
Growth and Development-related Outcomes in Children With Transfusion-dependent Beta-thalassemia After Gene Therapy
Transfusion-dependent Beta-Thalassemia, Gene Therapy
Not yet recruiting
Gene Therapy of Beta Thalassemia Using a Self-inactivating Lentiviral Vector
Beta-Thalassemia
RecruitingPhase 1/2
β-Thalassemia Treatment With KL003 Cell Injection
Transfusion-dependent Beta-Thalassemia
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Mitapivat in Participants With Non-Transfusion-Dependent Alpha- or Beta-Thalassemia (α- or β-NTDT)
Non-Transfusion-dependent Alpha-Thalassemia, Non-Transfusion-dependent Beta-Thalassemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Beta Thalassemia, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangmin Xu, Prof. Dr. ((20) 61648293 ext. 86, xixm@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiogram (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.