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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06039969
Other study ID # 20230911
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date October 1, 2025

Study information

Verified date September 2023
Source Nanjing Medical University
Contact Jin Geng, MD
Phone +86-17753124846
Email gj885258@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date October 1, 2025
Est. primary completion date October 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Locations

Country Name City State
China Huai'An First People'S Hospital Huai'an Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other cardiac fitiness Assessment of caridac fitness based on ardiopulmonary exercise test first admission six months one year
Primary myocardial fibrosis Assessment of myocardial fibrosis based on cardiac MRI examination first admission six months one year
Secondary Bacterial spectrum of intestine Assessment of Bacterial spectrum of intestine based on Patient feces sequencing first admission six months one year
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