Clinical trial NCT04851652: Observational Study for Patients With Hypertrophic Cardiomyopathy
Official title: Observational Study for Patients With Hypertrophic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HCM - Hypertrophic Cardiomyopathy
Keywords: all-cause mortality
cardiovascular death
hospitalization for heart failure
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with hypertrophic cardiomyopathy by medical history, physical examination and echocardiography.

Brief summary: Observational study on patients with hypertrophic cardiomyopathy aims to investigate the correlation between cardiac fibrosis, as indicated by cardiac magnetic resonance, and the prognosis, and further to explore biomarkers for cardiac fibrosis and adverse prognosis of hypertrophic cardiomyopathy. Therefore, endpoints including all-cause mortality, cardiovascular death, ventricular arrythmia, non-fatal stroke, non-fatal myocardial infarction, sudden death, successful cardiopulmonary resuscitation will be evaluated.

Detailed description: In this observational study on patients with hypertrophic cardiomyopathy, 500 eligible patients, who were diagnosed as hypertrophic cardiomyopathy by echocardiography, will be recruited with a median follow up of 5 years. Patients will be excluded who develop cardiac hypertrophy caused by other factors such as hypertension, diabetes, myocardial amyloidosis, mitochondria cardiomyopathy, congenital heart disease, etc; who have underwent heart transplantation; who are not suitable for the present study due to malignant tumor or severe trauma.

Eligible individuals, identified based on echocardiography and medical records, were invited by phone to a community clinic for visit. For eligible individuals, study data were comprised of a self-administered questionnaire, anthropometric features, laboratory examinations, echocardiographic and/or cardiac magetic resonance data. Anthropometric data were measured by experienced research staff in the morning under standardized conditions. Echocardiographic measuring were performed by three skilled sonographers independently, based on routine protocols on an HP5500 (Phillips Medical System, Boston, Massachusetts, USA) per current guidelines. Venous blood samples were collected in the morning following overnight fasting. Laboratory procedures were performed under standardized conditions.

Endpoints including all-cause mortality, cardiovascular death, sudden death (ICD-Code I46.1, R96), ventricular tachycardia(ICD-code I47.2)/fibrillation/flutter(ICD-code I49.0), hospitalization for heart failure(ICD-Code I50), heart transplatation ((ICD-Code Z94.1), non-fatal stroke(ICD-Code I60, I61, I63, I64), non-fatal myocardial infarction (ICD-Code I21), sudden death (ICD-Code I46.1, R96), successful cardiopulmonary resuscitation (ICD-Code I46.0) will be evaulated.

Across the whole observational study, 50 endpoints are anticipated to occur annually, and therefore the sample size was estimated to be approximately 500 subjects.

Data collection and management will be conducted via electronic data collection (EDC). Source data will be checked regularly to assess the accuracy and completeness. For statistical analysis, For continuous variables are presented as mean±standard deviation (SD), and compared by the Student t-test. Categorical variables were presented as frequency and assessed by the χ2 test. SAS 9.4 for Windows (release 6.11, USA) was utilized for statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with hypertrophic cardiomyopathy by medical history, physical examination and echocardiography.

Exclusion Criteria:

* Patients with cardiac hypertrophy caused by other factors such as hypertension, diabetes, myocardial amyloidosis, mitochondria cardiomyopathy, congenital heart disease, valvular heart disease, etc; Patients who had underwent heart transplatation; Individuals not suitable for the present study due to maligant tumor or severe trauma will be excluded.

Primary outcomes:
measure: All-cause death
timeFrame: 5 YEARS
Secondary outcomes:
measure: Cardiovascular death
timeFrame: 5 YEARS
measure: Ventricular tachycardia
timeFrame: 5 YEARS.
measure: Ventricular fibrillation and flutter
timeFrame: 5 YEARS.
measure: nonfatal stroke
timeFrame: 5 YEARS.
measure: nonfatal myocardial infarction
timeFrame: 5 YEARS.
measure: sudden death
timeFrame: 5 YEARS.
measure: Cardiac arrest with successful resuscitation
timeFrame: 5 YEARS.
measure: Hospitalization for heart failure
timeFrame: 5 YEARS
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong cardiovascular institute
state: Guangdong
Study officials:
affiliation: Guangdong Cardiovascular institute
name: Cheng Huang, PhD
role: STUDY_DIRECTOR
References: