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Outcome of Different Pathogenic Mutations in Hypertrophic Cardiomyopathy

The Clinical Outcome and Prognosis of Patients With Different Pathogenic Mutations of Hypertrophic Cardiomyopathy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03726424
Enrollment
1000
Registered
2018-10-31
Start date
2011-02-25
Completion date
2019-12-31
Last updated
2018-11-05

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

Conditions

Hypertrophic Cardiomyopathy

Keywords

pathogenic mutations, clinical phenotype, prognosis

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.

Interventions

None listed

Sponsors

Tongji Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Cardiovascular mortalityup to 60 monthsDeath from cardiovascular disease which includes coronary artery diseases, stroke, heart failure, hypertensive heart disease, rheumatic heart disease, cardiomyopathy, heart arrhythmia, congenital heart disease, valvular heart disease, carditis, aortic aneurysms, peripheral artery disease, thromboembolic disease, and venous thrombosis
Rate of heart transplantationup to 60 monthsHeart transplantation is a surgical transplant procedure performed on patients with end-stage heart failure or severe coronary artery disease when other medical or surgical treatments have failed
Rate of nonfatal strokeup to 60 months
Rate of nonfatal myocardial infarctionup to 60 months

Secondary

MeasureTime frame
Readmission rate for cardiovascular diseasesup to 60 months
Recurrence rate of heart failureup to 60 months
All-cause mortalityup to 60 months

Countries

China

Contacts

Primary ContactJia Qi Dai, MD candidate
d201781397@hust.edu.cn86-27-83663280

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026