Outcome of Different Pathogenic Mutations in Hypertrophic Cardiomyopathy

NCT ID: NCT03726424

Last Updated: 2018-11-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-25
• Study Completion Date: 2019-12-31

Brief Summary

This is a prospective, single-center study to assess clinical phenotype and prognosis of different pathogenic mutations in Chinese patients with hypertrophic cardiomyopathy. Patients with hypertrophic cardiomyopathy were consecutively recruited, and then DNA samples were extracted from peripheral blood. Targeted sequencing of 142 genes was performed to obtain variants associated with hypertrophic cardiomyopathy. Patients will undergo face-to-face interviews, phone calls, or/and chart reviews at 6 months, 12 months, 24 months, 36 months, 48 months and 60 months for data collection of clinical outcomes.

Conditions

Hypertrophic Cardiomyopathy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

mutation

patients carrying one or more specific pathogenic mutations

No interventions assigned to this group

control

patients not carrying the pathogenic mutation(s)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 1. Adults: a wall thickness ≥15 mm in one or more LV myocardial segments-as measured by any imaging technique (echocardiography, cardiac magnetic resonance imaging (CMR) or computed tomography (CT))-that is not explained solely by loading conditions;
• 2. Children: an LV wall thickness more than two standard deviations greater than the predicted mean (z-scored>2, where a z-score is defined as the number of standard deviations from the population mean);
• 3. Relatives: the first-degree relatives of patients with unequivocal disease (LVH ≥15 mm) is based on the presence of otherwise unexplained increased LV wall thickness ≥13 mm in one or more LV myocardial segments, as measured using any cardiac imaging technique [echocardiography, cardiac magnetic resonance (CMR) or CT].

Exclusion Criteria

• 1. Patients with severe valvular disease, aortic stenosis, congenital heart disease, hypertensive heart disease, diabetic cardiomyopathy, or other cardiovascular or systemic diseases that may cause ventricular hypertrophy;
• 2. Patients who had participated in any clinical trial during the first 3 months;
• 3. Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix);
• 4. Patients refused to comply with the requirements of this study to complete the research work.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dao Wen Wang

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dao Wen Wang, Doctor

Role: STUDY_CHAIR

Tongji Hospital,Wuhan, Hubei, China, 430030

Locations

Tongji Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jia Qi Dai, MD candidate

Role: CONTACT

d201781397@hust.edu.cn

86-27-83663280

Facility Contacts

Jia Qi Dai, MD candidate

Role: primary

d201781397@hust.edu.cn

86-27-83663280

Other Identifiers

PPOHPM

Identifier Type: -

Identifier Source: org_study_id