NCT05871632

Brief Summary

Cardiomyopathy is the most common inherited cardiovascular disease, showing family aggregation, so it has a huge psychological and economic burden on family members. Studying the clinical characteristics of patients with cardiomyopathy is helpful for further diagnosis, treatment and management, which has important clinical and social significance.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
14mo left

Started Jul 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress72%
Jul 2023Jun 2027

First Submitted

Initial submission to the registry

May 10, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Expected
Last Updated

May 23, 2023

Status Verified

May 1, 2023

Enrollment Period

2 years

First QC Date

May 10, 2023

Last Update Submit

May 13, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of participants with cardiovascular deaths

    including sudden cardiac death and deaths due to heart failure and stroke

    an average of 1 year

Secondary Outcomes (4)

  • number of participants with heart failure

    an average of 1 year

  • number of participants with stroke

    an average of 1 year

  • number of participants with myocardial infarction

    an average of 1 year

  • number of participants with all-cause deaths

    an average of 1 year

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized with cardiomyopathy as the primary discharge diagnosis are recruited prospectively from multiple centers in China between July 1, 2023 and June 30, 2025.

You may qualify if:

  • Patients with primary discharge diagnosis meeting one of the following subtypes of cardiomyopathy were enrolled, including HCM, DCM, ACM, RCM, left ventricular non-compaction, cardiac amyloidosis, Fabry disease, Pompe disease, Danon disease, and PRKAG2 cardiac syndrome.

You may not qualify if:

  • Patients who refuse to sign the informed consent or decline follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Cardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Lei Song, MD.&phD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

May 10, 2023

First Posted

May 23, 2023

Study Start

July 1, 2023

Primary Completion

June 30, 2025

Study Completion (Estimated)

June 30, 2027

Last Updated

May 23, 2023

Record last verified: 2023-05

Locations