Evaluate Aerobic Exercise on Myocardial Fibrosis and Inte... | NCT06039969

Studies
Evaluate Aerobic Exercise on Myocardial Fibrosis and Intestinal Flora in Dilated Cardiomyopathy Diagnosed First Time.

NCT06039969

Sponsor

Nanjing Medical University

Status

Unknown status

Last Update Posted

Sep 15, 2023Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Cardiac Rehabilitation
Myocardial Fibrosis

Interventions

Not provided

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

Sep 2023

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

Oct 1, 2023Estimated

Primary Completion Date

Oct 1, 2024Estimated

Completion Date

Oct 1, 2025Estimated

First Submitted Date

Sep 11, 2023

First Submission Date that Met QC Criteria

Sep 11, 2023

First Posted Date

Sep 15, 2023Actual

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

Sep 11, 2023

Last Update Posted Date

Sep 15, 2023Actual

Description Module

Brief Summary

To invegstive the Changes of Intestinal Flora and the improvements of Cardiac Fibrosis in Patients With Dilated Cardiomyopathy Diagnosed for the First Time by heart Rehabilitation

Detailed Description

Previous studies have confirmed that Aerobic exercise rehabilitation can reduce the rate of readmission of patients with heart failure and improve their cardiopulmonary endurance and exercise ability. However, whether aerobic exercise rehabilitation can inhibit myocardial fibrosis or delay the progress of fibrosis in patients with heart failure has not been reported. At the same time, some studies have shown that the change of intestinal microbial flora may promote the progress of heart failure, and regular aerobic exercise will also lead to the change of intestinal microbial flora, but whether aerobic exercise rehabilitation can improve intestinal microbial flora in patients with dilated cardiomyopathy has not been reported. In our study, patients who were hospitalized for heart failure for the first time and were finally diagnosed with dilated cardiomyopathy were recruited. Recruited patients will enter the routine cardiac rehabilitation process and make an individualized aerobic exercise plan according to the cardiopulmonary exercise test. Cardiac MRI and intestinal microflora changes will be evaluated.

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

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiac MRI will be performed in patients with heart failure caused by cardiomyopathy.		Cardiac MRI will be performed in patients with heart failure caused by cardiomyopathy. At the same time Collect patient feces.this is a obvertional study ,ther is no intervetion

Interventions

Name	Type	Description	Arm Group Labels	Other Names
	Other	This is an obvertional study and there is no intervention	Cardiac MRI will be performed in patients with heart failure caused by cardiomyopathy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
myocardial fibrosis	Assessment of myocardial fibrosis based on cardiac MRI examination	first admission six months one year

Secondary Outcomes

Measure	Description	Time Frame
Bacterial spectrum of intestine	Assessment of Bacterial spectrum of intestine based on Patient feces sequencing	first admission six months one year

Other Outcomes

Measure	Description	Time Frame
cardiac fitiness	Assessment of caridac fitness based on ardiopulmonary exercise test	first admission six months one year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1、Patients hospitalized for the first time because of heart failure 2、The patient who was definitely diagnosed as dilated cardiomyopathy for the first time

Exclusion Criteria:

1、Other types of cardiomyopathy 2、Has been diagnosed as dilated cardiomyopathy. 3、malignant tumor 4、acute infection 5、Cannot perform cardiopulmonary exercise test.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

patients who were hospitalized for heart failure for the first time and were finally diagnosed with dilated cardiomyopathy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jin Geng, MD	Contact	+86-17753124846		gj885258@163.com
XiWen Zhang, MD	Contact

Overall Officials

Name	Affiliation	Role
XiWen Zhang, MD	Huai'an First People's Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huai'An First People'S Hospital	Recruiting	Huai'an	Jiangsu	223300	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided