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Outcome of Different Pathogenic Mutations in Hypertrophic Cardiomyopathy

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

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

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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


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



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


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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726424


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

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

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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    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018

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