Observational Study for Patients With Hypertrophic Cardiomyopathy

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.

Study Overview

• Status: Recruiting
• Conditions: HCM - Hypertrophic Cardiomyopathy
• Intervention / Treatment: Other: No intervention nor exposure

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Cheng Huang, PhD; Phone Number: 020-83827812 020-83827812; Email: linfeng7822@sina.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong Cardiovascular Institute
      • Contact: Cheng Huang, PhD; Phone Number: 020-83827812 20-83827812; Email: linfeng7822@sina.com
      • Contact: Qi Zhong, PhD; Phone Number: 020-83827812 020-83827812; Email: zhongqi219@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	All-cause mortality refers to death from any causes.	5 YEARS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular death	Cardiovascular death include death caused by stroke, MI, HF, sudden death or any other death attributed to cardiovascular diseases.	5 YEARS
Ventricular tachycardia	Ventricular tachycardia is an abnormally fast heart beat (with three or more consecutive heart beats at least 100 beats per minute) that originates from one of the ventricles in the heart (ICD-code I47.2).	5 YEARS.
Ventricular fibrillation and flutter	Ventricular fibrillation (VF) is a very rapid (150-500 bpm) irregularly irregular disorganized ventricular rhythm of varying configuration; with time, the amplitude of the fibrillation wave becomes progressively smaller, particularly immediately before death. Ventricular flutter (VFL) is a very rapid (180-250 bpm) and regular ectopic ventricular rhythm with undulations of equal amplitude and usually rapidly degenerates to VF(ICD-code I49.0).	5 YEARS.
nonfatal stroke	Stroke (ICD-Code I60, I61, I63, I64) is a focal neurological deficit with symptoms continuing for more than 24 hours or leading to death with no apparent cause other than vascular. Stroke as an endpoint in this study includes definite ischemic stroke, primary intracerebral hemorrhage and subarachnoid hemorrhage with evidence from CT or MRI scan within 14 days of onset or autopsy confirmation, and stroke of unknown type etiology when CT, MRI, or autopsy are not done and information is inadequate to diagnose the etiology definitely.	5 YEARS.
nonfatal myocardial infarction	Acute myocardial infarction (MI) (ICD-Code I21) is defined when any one of the following criteria occurs. (1) Detection of a rise and/or fall of cardiac biomarker values, with at least one value above the 99th percentile upper reference limit and with at least one of the following manifestations: symptoms of ischaemia that should have lasted for at least 30 minutes and should not have been responsive to sublingual administration of nitrates; new or presumed new significant ST-segment-T wave changes or new left bundle branch block (LBBB); development of pathological Q waves in the ECG; imaging evidence of new loss of viable myocardium or new regional wall motion abnormality. (2) Identification of an intracoronary thrombus by angiography or autopsy. (3) Cardiac death with symptoms suggestive of myocardial ischaemia and presumed new ischaemic ECG changes or new LBBB, but death occurred before cardiac biomarkers were obtained, or before cardiac biomarker values would be increased.	5 YEARS.
sudden death	Sudden death (ICD-Code I46.1, R96) encompasses any death of unknown origin occurring instantly or within an estimated 24 hours after the onset of acute symptoms as well as unattended death for which no likely cause can be established by autopsy or recent medical history.	5 YEARS.
Cardiac arrest with successful resuscitation	ICD-Code I46.0	5 YEARS.
Hospitalization for heart failure	Congestive heart failure (HF) (ICD-Code I50) requires the presence of three conditions, namely symptoms, such as dyspnea, clinical signs, such as ankle edema or crepitations, and the necessity to initiate treatment with open-label diuretics, vasodilators or antihypertensive drugs. HF cases may also be adjudicated as chronic stable HF but this is not considered an outcome of the present study.	5 YEARS

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Study Director: Cheng Huang, PhD, Guangdong Cardiovascular Institute

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: April 11, 2021
• First Submitted That Met QC Criteria: April 17, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 17, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: all-cause mortality; hospitalization for heart failure; cardiovascular death
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Hypertrophy; Cardiomyopathies; Cardiomyopathy, Hypertrophic
• Other Study ID Numbers: GDREC2019545HR1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Majority of participants do not want their private information to be shared by other reserchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No