NCT04929574

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

June 18, 2021

Status Verified

May 1, 2021

Enrollment Period

3 years

First QC Date

June 3, 2021

Last Update Submit

June 16, 2021

Conditions

Beta Thalassemia

Outcome Measures

Primary Outcomes (1)

  • Echocardiogram

    Evaluation of heart function in beta thalassemia patients by left ventricular fraction shortening

    3 years

Study Arms (1)

beta thalassemia patients

Diagnostic Test: Echocardiogram and Hematological Analysis

Interventions

Echocardiogram and Hematological AnalysisDIAGNOSTIC_TEST

Echocardiogram and Hematological Analysis

beta thalassemia patients

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

beta thalassemia patients from Southern China

You may qualify if:

  • Diagnosed with beta-thalassemia

You may not qualify if:

  • Iron deficiency anemia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

beta-Thalassemia

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

ThalassemiaAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Central Study Contacts

Xiangmin Xu, Prof. Dr.

CONTACT

(20) 61648293xixm@smu.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2021

First Posted

June 18, 2021

Study Start

July 1, 2021

Primary Completion

July 1, 2024

Study Completion

December 30, 2025

Last Updated

June 18, 2021

Record last verified: 2021-05

Locations

CN(1)