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

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ClinicalTrials.gov Identifier: NCT06039969
Recruitment Status : Recruiting
First Posted : September 15, 2023
Last Update Posted : September 15, 2023
Sponsor:
Information provided by (Responsible Party):
Jin Geng, Nanjing Medical University

Study Description
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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

Condition or disease
Cardiac Rehabilitation Myocardial Fibrosis

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.
Study Design
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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Study on the Changes of Intestinal Flora and Cardiac Fibrosis in Patients With Dilated Cardiomyopathy Diagnosed for the First Time by Sports Rehabilitation
Estimated Study Start Date : October 1, 2023
Estimated Primary Completion Date : October 1, 2024
Estimated Study Completion Date : October 1, 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. myocardial fibrosis [ Time Frame: first admission six months one year ]
    Assessment of myocardial fibrosis based on cardiac MRI examination


Secondary Outcome Measures :
  1. Bacterial spectrum of intestine [ Time Frame: first admission six months one year ]
    Assessment of Bacterial spectrum of intestine based on Patient feces sequencing


Other Outcome Measures:
  1. cardiac fitiness [ Time Frame: first admission six months one year ]
    Assessment of caridac fitness based on ardiopulmonary exercise test


Biospecimen Retention:   Samples Without DNA
Cardiac MRI data and patient's feces will be collected.Changes in intestinal flora spectrum will be detected.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients who were hospitalized for heart failure for the first time and were finally diagnosed with dilated cardiomyopathy
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06039969


Contacts
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Contact: Jin Geng, MD +86-17753124846 gj885258@163.com
Contact: XiWen Zhang, MD

Locations
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China, Jiangsu
Huai'An First People'S Hospital Recruiting
Huai'an, Jiangsu, China, 223300
Contact: Xiaozhong Yang, MD         
Sub-Investigator: Hailang Liu, MM         
Sponsors and Collaborators
Nanjing Medical University
Investigators
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Study Director: XiWen Zhang, MD Huai'an First People's Hospital
More Information
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Responsible Party: Jin Geng, associate doctor, Nanjing Medical University
ClinicalTrials.gov Identifier: NCT06039969    
Other Study ID Numbers: 20230911
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: September 15, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jin Geng, Nanjing Medical University:
Aerobic exercise rehabilitation
Myocardial Fibrosis
human gut microbiome
cardiac magnetic resonance
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Dilated
Fibrosis
Pathologic Processes
Heart Diseases
 Cardiovascular Diseases
Cardiomegaly
Laminopathies
Genetic Diseases, Inborn