A clinical study to evaluate the effectiveness of a human cardiomyopathy gene combination test kit in patients with cardiomyopathy

Status

Recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2500104918

Enrollment

Unknown

Registered

2025-06-25

Start date

2025-04-21

Completion date

Unknown

Last updated

2025-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy (HCM) and Dilated Cardiomyopathy (DCM)?

Interventions

observation group:NA

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Subjects aged 18-80 years, regardless of gender. 2. Anticoagulated whole blood samples from clinically diagnosed hypertrophic cardiomyopathy (HCM) or dilated cardiomyopathy (DCM) patients. 3. Samples collected in sodium citrate or EDTA anticoagulant tubes with a volume of 5 mL. 4. Complete clinical documentation available for all specimens.

Exclusion criteria

Exclusion criteria: 1. Samples with volume <5.0 mL; 2. Specimens rendered unusable due to instrument malfunction or human operational errors during testing; 3. Samples with incomplete medical records, which shall be classified as invalid specimens.

Design outcomes

Primary

Measure	Time frame
Positive Detection Rate (PDR)?;	—

Countries

China

Contacts

Public ContactJi Yuan

Zhongshan Hospital, Fudan University

ji.yuan@zs-hospital.sh.cn+86 13681858366

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026