NCT04837612

Brief Summary

Observational study on patients with dilated cardiomyopathy aims to investigate the correlation between cardiac fibrosis, as indicated by cardiac magnetic resonance, and the prognosis of patients with dilated cardiomyopathy, and further to explore biomarkers for cardiac fibrosis and adverse prognosis of dilated cardiomyopathy. Therefore, endpoints indluding all-cause mortality, cardiovascular death, ventricular arrythmia, non-fatal stroke, non-fatal myocardial infarction, sudden death, successful cardiopulmonary resuscitation will be evaluated.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

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

Study Start

First participant enrolled

January 1, 2019

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 8, 2021

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
Last Updated

April 8, 2021

Status Verified

April 1, 2021

Enrollment Period

6 years

First QC Date

April 6, 2021

Last Update Submit

April 6, 2021

Conditions

Keywords

all-cause mortalitycardiovascular deathhospitalization for heart failureheart transplatation

Outcome Measures

Primary Outcomes (1)

  • All-cause death

    All-cause mortality refers to death from any causes.

    5 YEARS.

Secondary Outcomes (8)

  • Cardiovascular death

    5 YEARS.

  • Ventricular tachycardia and fibrillation and flutter

    5 YEARS.

  • nonfatal stroke

    5 YEARS.

  • nonfatal myocardial infarction

    5 YEARS.

  • sudden death

    5 YEARS.

  • +3 more secondary outcomes

Study Arms (1)

Subjects with dilated cardiomyopathy

Subjects diagnosed with dilated cardiomyopathy by medical history, physical examination and echocardiography.

Other: No intervention nor exposure

Interventions

As an observational study, no intervention nor exposure is interested.

Subjects with dilated cardiomyopathy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with dilated cardiomyopathy by medical history, physical examination and echocardiography.

You may not qualify if:

  • Cardiac enlargement caused by other factors such as myocardial ischemia, myocarditis, diabetic cardiomyopathy, valvular heart disease, congenital heart disease, Patients who had underwent heart transplatation. Individuals not suitable for the present study due to maligant tumor or severe trauma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong cardiovascular institute

Guangzhou, Guangdong, 510080, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, whole blood, and white blood cells

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Cheng Huang, PhD

    Guangdong Cardiovascular institute, Dongchuan Road,96#, Guangzhou City, Guangdong Province

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheng Huang, PhD

CONTACT

Qi Zhong, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PROFESSOR

Study Record Dates

First Submitted

April 6, 2021

First Posted

April 8, 2021

Study Start

January 1, 2019

Primary Completion

January 1, 2025

Study Completion

January 1, 2025

Last Updated

April 8, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

A part of participants do not want their privacy to be shared by other reserchers.

Locations