Cardiac RehabilitationNCT06039969
Evaluate Aerobic Exercise on Myocardial Fibrosis and Intestinal Flora in Dilated Cardiomyopathy Diagnosed First Time.
An observational study of Cardiac Rehabilitation and Myocardial Fibrosis, run by Nanjing Medical University at 1 site in China.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiac Rehabilitation, Myocardial Fibrosis
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 1 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who were hospitalized for heart failure for the first time and were finally diagnosed with dilated cardiomyopathy
Who may be able to join
- 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
Who cannot join
- 1、Other types of cardiomyopathy 2、Has been diagnosed as dilated cardiomyopathy. 3、malignant tumor 4、acute infection 5、Cannot perform cardiopulmonary exercise test.
Trial locations and contacts
1 site in 1 country.
XiWen Zhang, MD contact
China1 site, 1 recruiting
- Recruiting
Huai'An First People'S Hospital
Huai'an, Jiangsu, 223300
Xiaozhong Yang, MD
Hailang Liu, MM
About this study
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
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
Read the 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.
- Conditions
- Cardiac Rehabilitation, Myocardial Fibrosis
- Keywords
- Aerobic exercise rehabilitation, Myocardial Fibrosis, human gut microbiome, cardiac magnetic resonance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other
This is an obvertional study and there is no intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial fibrosis
Assessment of myocardial fibrosis based on cardiac MRI examination
Measured: first admission six months one year
Secondary outcomes (1)
Bacterial spectrum of intestine
Assessment of Bacterial spectrum of intestine based on Patient feces sequencing
Measured: first admission six months one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- More trials run by Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Geng, Nanjing Medical University
- Investigators
- XiWen Zhang, MD, Study director, Huai'an First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06039969
- Sponsor's protocol ID
- 20230911
- Status last verified
- Sep 2023
- First submitted
- 11 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06039969
- Acronym / sponsor ID
- 20230911
- Conditions
- Cardiac Rehabilitation, Myocardial Fibrosis
- Keywords
- Aerobic exercise rehabilitation, Myocardial Fibrosis, human gut microbiome, cardiac magnetic resonance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 15 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who were hospitalized for heart failure for the first time and were finally diagnosed with dilated cardiomyopathy
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 1、Other types of cardiomyopathy 2、Has been diagnosed as dilated cardiomyopathy. 3、malignant tumor 4、acute infection 5、Cannot perform cardiopulmonary exercise test.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is an obvertional study and there is no intervention | Other | Cardiac MRI will be performed in patients with heart failure caused by cardiomyopathy. |
Primary outcome
myocardial fibrosis
Time frame: first admission six months one year
Assessment of myocardial fibrosis based on cardiac MRI examination
1 secondary outcome
Bacterial spectrum of intestine
Time frame: first admission six months one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
XiWen Zhang, MD contact
XiWen Zhang, MD study director
Huai'an First People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Rehabilitation and Myocardial Fibrosis, run by Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Geng, MD (+86-17753124846, gj885258@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial fibrosis (time frame: first admission six months one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.