Outcome of Different Pathogenic Mutations in Hypertrophic Cardiomyopathy

NCT03726424 | Unknown

• 1 other identifier: PPOHPM
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertrophic Cardiomyopathy

Keywords

pathogenic mutations; clinical phenotype; prognosis

Outcome Measures

Primary Outcomes (4)

• Cardiovascular mortality

  Death 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

  up to 60 months

• Rate of heart transplantation

  Heart 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

  up to 60 months

• Rate of nonfatal stroke

  up to 60 months

• Rate of nonfatal myocardial infarction

  up to 60 months

Secondary Outcomes (3)

• All-cause mortality

  up to 60 months

• Readmission rate for cardiovascular diseases

  up to 60 months

• Recurrence rate of heart failure

  up to 60 months

Study Arms (2)

mutation

patients carrying one or more specific pathogenic mutations

control

patients not carrying the pathogenic mutation(s)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with hypertrophic cardiomyopathy

You may qualify if:

• \. 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;
• \. 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);
• \. 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 \[echocardiography, cardiac magnetic resonance (CMR) or CT\].

You may not qualify if:

• \. 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;
• \. Patients who had participated in any clinical trial during the first 3 months;
• \. 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);
• \. Patients refused to comply with the requirements of this study to complete the research work.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

peripheral blood

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Officials

• Dao Wen Wang, Doctor

  Tongji Hospital,Wuhan, Hubei, China, 430030

  STUDY CHAIR

Central Study Contacts

Jia Qi Dai, MD candidate

CONTACT

86-27-83663280; d201781397@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 30, 2018
• First Posted: October 31, 2018
• Study Start: February 25, 2011
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: November 5, 2018

Record last verified: 2018-11

Locations

CN (1)