Evaluation of Heart Status in Patients of Beta Thalassemi... | NCT04929574

Studies
Evaluation of Heart Status in Patients of Beta Thalassemia Using Echocardiogram

NCT04929574

Sponsor

Nanfang Hospital, Southern Medical University

Status

Unknown status

Last Update Posted

Jun 18, 2021Actual

Enrollment

1,200Estimated

Phase

Not provided

Conditions

Beta Thalassemia

Interventions

Echocardiogram and Hematological Analysis

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2021Estimated

Primary Completion Date

Jul 1, 2024Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Jun 3, 2021

First Submission Date that Met QC Criteria

Jun 16, 2021

First Posted Date

Jun 18, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2021

Last Update Posted Date

Jun 18, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Nanfang Hospital, Southern Medical UniversityOTHER

Collaborators

Name	Class
ZhuHai Hospital	OTHER
Shenzhen Children's Hospital	OTHER_GOV
Shenzhen Second People's Hospital	OTHER
Jiangmen Maternity and Child Health Care Hospital

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
beta thalassemia patients			Diagnostic Test: Echocardiogram and Hematological Analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Echocardiogram and Hematological Analysis	Diagnostic Test	Echocardiogram and Hematological Analysis	beta thalassemia patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Echocardiogram	Evaluation of heart function in beta thalassemia patients by left ventricular fraction shortening	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with beta-thalassemia

Exclusion Criteria:

Iron deficiency anemia

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

beta thalassemia patients from Southern China

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiangmin Xu, Prof. Dr.	Contact	(20) 61648293	86	xixm@smu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Southern Medical University	Recruiting	Guangzhou	Guangdong	510515	China

Condition Browse Module

MeSH Terms

ID	Term
D017086	beta-Thalassemia

Ancestor Terms

ID	Term
D013789	Thalassemia
D000745	Anemia, Hemolytic, Congenital
D000743	Anemia, Hemolytic
D000740	Anemia

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004452	Echocardiography

Ancestor Terms

ID	Term
D057791	Cardiac Imaging Techniques
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided