Observational Study for Patients With Hypertrophic Cardiomyopathy

Observational Study for Patients With Hypertrophic Cardiomyopathy

Sponsors

Lead Sponsor: Guangdong Provincial People's Hospital

Source Guangdong Provincial People's Hospital
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.

Overall Status Recruiting
Start Date 2021-06-01
Completion Date 2025-12-31
Primary Completion Date 2025-12-31
Study Type Observational
Primary Outcome
Measure Time Frame
All-cause death 5 YEARS
Secondary Outcome
Measure Time Frame
Cardiovascular death 5 YEARS
Ventricular tachycardia 5 YEARS.
Ventricular fibrillation and flutter 5 YEARS.
nonfatal stroke 5 YEARS.
nonfatal myocardial infarction 5 YEARS.
sudden death 5 YEARS.
Cardiac arrest with successful resuscitation 5 YEARS.
Hospitalization for heart failure 5 YEARS
Enrollment 500
Condition
Intervention

Intervention Type: Other

Intervention Name: No intervention nor exposure

Description: As an observational study, no intervention nor exposure is interested.

Eligibility

Sampling Method:

Non-Probability Sample

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.

Gender:

All

Minimum Age:

N/A

Maximum Age:

N/A

Overall Official
Last Name Role Affiliation
Cheng Huang, PhD Study Director Guangdong Cardiovascular institute
Overall Contact

Last Name: Cheng Huang, PhD

Phone: 020-83827812

Phone Ext.: 020-83827812

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Guangdong cardiovascular institute Cheng Huang, PhD 20-83827812 020-83827812 [email protected]
Location Countries

China

Verification Date

2021-04-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Guangdong Provincial People's Hospital

Investigator Full Name: Cheng Huang

Investigator Title: PhD

Keywords
Has Expanded Access No
Condition Browse
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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