Outcome of Different Pathogenic Mutations in Hypertrophic Cardiomyopathy

• ClinicalTrials.gov Identifier: NCT03726424
• Recruitment Status: Recruiting
• First Posted: October 31, 2018
• Last Update Posted: November 5, 2018
• Sponsor: Tongji Hospital
• Information provided by (Responsible Party): Dao Wen Wang, Tongji Hospital

Study Description

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.

Condition or disease
Hypertrophic Cardiomyopathy

Study Design

• Study Type: Observational
• Estimated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Clinical Outcome and Prognosis of Patients With Different Pathogenic Mutations of Hypertrophic Cardiomyopathy
• Actual Study Start Date: February 25, 2011
• Estimated Primary Completion Date: December 31, 2019
• Estimated Study Completion Date: December 31, 2019

Groups and Cohorts

Group/Cohort
mutation; patients carrying one or more specific pathogenic mutations
control; patients not carrying the pathogenic mutation(s)

Outcome Measures

Primary Outcome Measures :

1. Cardiovascular mortality [ Time Frame: up to 60 months ]
   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
2. Rate of heart transplantation [ Time Frame: up to 60 months ]
   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
3. Rate of nonfatal stroke [ Time Frame: up to 60 months ]
4. Rate of nonfatal myocardial infarction [ Time Frame: up to 60 months ]

Secondary Outcome Measures :

1. All-cause mortality [ Time Frame: up to 60 months ]
2. Readmission rate for cardiovascular diseases [ Time Frame: up to 60 months ]
3. Recurrence rate of heart failure [ Time Frame: up to 60 months ]

Biospecimen Retention:   Samples With DNA

peripheral blood

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with hypertrophic cardiomyopathy

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.

Contacts and Locations

Contacts

Contact: Jia Qi Dai, MD candidate; 86-27-83663280; d201781397@hust.edu.cn

Locations

China, Hubei

Tongji Hospital; Recruiting

Wuhan, Hubei, China, 430030

Contact: Jia Qi Dai, MD candidate 86-27-83663280 d201781397@hust.edu.cn

Sponsors and Collaborators

Tongji Hospital

Investigators

• Study Chair: Dao Wen Wang, Doctor; Tongji Hospital,Wuhan, Hubei, China, 430030

More Information

• Responsible Party: Dao Wen Wang, Prof., Tongji Hospital
• ClinicalTrials.gov Identifier: NCT03726424 History of Changes
• Other Study ID Numbers: PPOHPM
• First Posted: October 31, 2018
• Last Update Posted: November 5, 2018
• Last Verified: November 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dao Wen Wang, Tongji Hospital:

pathogenic mutations; clinical phenotype; prognosis

Additional relevant MeSH terms:

Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Heart Valve Diseases