Clinical trial NCT03726424: Outcome of Different Pathogenic Mutations in Hypertrophic Cardiomyopathy
Official title: The Clinical Outcome and Prognosis of Patients With Different Pathogenic Mutations of Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertrophic Cardiomyopathy
Keywords: pathogenic mutations
clinical phenotype
prognosis
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hypertrophic cardiomyopathy

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.


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.

Primary outcomes:
measure: Cardiovascular mortality
timeFrame: up to 60 months
measure: Rate of heart transplantation
timeFrame: up to 60 months
measure: Rate of nonfatal stroke
timeFrame: up to 60 months
measure: Rate of nonfatal myocardial infarction
timeFrame: up to 60 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: up to 60 months
measure: Readmission rate for cardiovascular diseases
timeFrame: up to 60 months
measure: Recurrence rate of heart failure
timeFrame: up to 60 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital,Wuhan, Hubei, China, 430030
name: Dao Wen Wang, Doctor
role: STUDY_CHAIR
References: