NCT06039969

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 11, 2023

Last Update Submit

September 11, 2023

Conditions

Keywords

Aerobic exercise rehabilitationMyocardial Fibrosishuman gut microbiomecardiac magnetic resonance

Outcome Measures

Primary Outcomes (1)

  • myocardial fibrosis

    Assessment of myocardial fibrosis based on cardiac MRI examination

    first admission six months one year

Secondary Outcomes (1)

  • Bacterial spectrum of intestine

    first admission six months one year

Other Outcomes (1)

  • cardiac fitiness

    first admission six months one year

Study Arms (1)

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huai'An First People'S Hospital

Huai'an, Jiangsu, 223300, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cardiac MRI data and patient's feces will be collected.Changes in intestinal flora spectrum will be detected.

Study Officials

  • XiWen Zhang, MD

    Huai'an First People's Hospital

    STUDY DIRECTOR

Central Study Contacts

XiWen Zhang, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate doctor

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 15, 2023

Study Start

October 1, 2023

Primary Completion

October 1, 2024

Study Completion

October 1, 2025

Last Updated

September 15, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations