- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05510180
CVD Risk Profile in Children With HCM
Cardiovascular Disease Risk Profile in Children With Hypertrophic Cardiomyopathy
Hypertrophic cardiomyopathy is a disease of the heart muscle that causes the heart to become thicker and this thickness places children at risk of heart rhythm problems, heart failure and sudden death.To decrease the risk of sudden death, health care providers generally counsel that the patient should stop all intense physical activity. While this recommendation may decrease the risk of sudden death it is unclear what the long term impact of reduced physical activity is on cardiovascular health in children with HCM.
Cardiovascular (CV) disease is a disease of the heart and blood vessels and is the cause of heart attacks in adults. There are many risk factors for the development of CV disease including genetics, medical conditions and lifestyle choices. While some studies in adults suggest that patients with HCM are at higher risk of poor cardiovascular health, this has not yet been assessed in children. Although, CV disease is generally thought of to be a disease of adults, there is a lot of information that suggests the development of CV disease starts early in life and therefore by promoting heart healthy lifestyles in children, it is possible that these children will becomes healthier adults.
The goal of this project is to assess risk factors for CV disease in a population of children with HCM at the two largest pediatric cardiac programs in Canada. This assessment will be to look at factors we can measure (e.g., weight, cholesterol levels) and patients' and families' perceptions of what it means to be heart healthy. It is hoped that through this project risk factors for heart disease, and poor "heart healthy" lifestyles choices, will be identified in order to develop strategies to decrease these risk factors in patients with HCM. With a better understanding of the families' perceptions of heart healthy behaviours, educational tools and resources for cardiovascular health promotion in patients with HCM can be developed.
Study Overview
Status
Conditions
Detailed Description
Hypertrophic cardiomyopathy (HCM) is an inherited cardiomyopathy with the hallmark feature of left ventricular hypertrophy primarily involving the ventricular septum. It is associated with an increased risk of arrhythmias and sudden cardiac death (SC) [Maron et al., 2016]. It is the most common genetic heart disease, with a prevalence of up to 1 in 200 in the general population.
It is widely acknowledged that regular physical activity is important for long-term CV health in the general population. Childhood obesity is on the rise in the general population and physicians may be compounding the risk in children with HCM due to the activity restrictions imposed on them. Given the significant emphasis placed on what physical activities patients with HCM should avoid, physicians may not be effectively communicating the importance of maintaining a heart healthy lifestyle, including the importance of regular physical activity, on long-term CV health. This theory could explain the high levels of inactivity and obesity seen in the adult population of individuals with HCM, which have important consequences on long-term health and well-being.
Little research has been done to examine the other markers of CV health in the adult population. In addition, there have not been any studies evaluating the CV disease risk profile of children and adolescents with HCM and whether the phenomenon seen in the adult population is also seen in pediatric patients. This study will fill an important gap which will allow for the development of safe interventions in this unique patient population focused on promoting life-long CV health.
The primary aims of the study are:
- To describe the CV disease risk behaviors and CV disease risk profile of children with HCM.
- To determine if children with HCM are at greater risk for acquired CV disease compared to the general population.
The secondary aim of the study are:
- To identify barriers to a heart healthy lifestyle.
- To identify both the children's and families' perception of a heart healthy lifestyle.
This study will employ multiple methods. The quantitative component will be a prospective cross-sectional study undertaken at two centers in Canada with a dedicated Heart Function and Cardiomyopathy Department. The quantitative component will be a prospective cross-sectional study undertaken at across pediatric cardiac centers in Canada who look after children with HCM.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 2B7
- Stollery Children's Hospital
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British Columbia
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Vancouver, British Columbia, Canada, V6H 3N1
- BC Children's Hospital
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1S1
- Children's Hospital
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
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Ontario
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Toronto, Ontario, Canada, M5G 1X8
- Hospital for Sick Children
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- CHU Sainte-Justine
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Montreal, Quebec, Canada, H4A 3J1
- Montreal Children's Hospital
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Quebec City, Quebec, Canada, G1V 4G2
- Centre Hospitalier De L'Universite Laval
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7N 0W8
- Jim Pattison Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients between 10 and 19 years of age meeting the diagnostic criteria for primary hypertrophic cardiomyopathy set in the American Heart Association guideline and their families will be included.
- Parents and/or guardians of children 10-19 years of age with hypertrophic cardiomyopathy.
- English speaking -
Exclusion Criteria:
- Secondary hypertrophic cardiomyopathy
- Structural congenital heart defects that has the potential to limit physical ability
- Significant physical disability as identified by the cardiologist that limits physical activity ability (e.g., neuromuscular disease)
- Significant cognitive disorder or language barrier as identified by the cardiologist that would limit the completion of an English-language survey
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 |
---|---|---|
CV disease risk factors
Time Frame: 2 weeks - Visit 2
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Healthy Hearts School Program Questionnaire
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2 weeks - Visit 2
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CV disease risk behaviours
Time Frame: 2 weeks - Visit 2
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Healthy Hearts School Program Questionnaire
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2 weeks - Visit 2
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Acquired CV disease
Time Frame: 2 weeks - Visit 2
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Healthy Hearts School Program Questionnaire
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2 weeks - Visit 2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart healthy lifestyle barriers
Time Frame: Baseline - Visit 1
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Self-Efficacy for Exercise Scale
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Baseline - Visit 1
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Heart healthy lifestyle barriers
Time Frame: Baseline - Visit 1
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PedsQL (Pediatric Quality of Life Inventory and Pediatric Quality of Life Inventory: Cardiac Module)
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Baseline - Visit 1
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Child's perception of heart healthy lifestyle
Time Frame: Baseline - Visit 1
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Habitual Activity Estimation Scale (HAES)
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Baseline - Visit 1
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Parents' perception of heart healthy lifestyle
Time Frame: Baseline - Visit 1
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Habitual Activity Estimation Scale (HAES)
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Baseline - Visit 1
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00083230
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypertrophic Cardiomyopathy
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French Cardiology SocietyCompleted1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy | 2- Obstructive Hypertrophic Cardiomyopathy | 3- Non Obstructive Hypertrophic CardiomyopathyFrance
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University of Sao PauloCompletedNon-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyBrazil
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Montreal Heart InstituteCanadian Institutes of Health Research (CIHR)Enrolling by invitationCardiomyopathies | Hypertrophic Cardiomyopathy | Hypertrophic Obstructive Cardiomyopathy | Familial Hypertrophic CardiomyopathyCanada
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Bristol-Myers SquibbActive, not recruitingHypertrophic Cardiomyopathy | Non-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyDenmark, United States, Belgium, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom
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Yonsei UniversityCompletedFamilial Hypertrophic CardiomyopathyKorea, Republic of
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Hangzhou Valgen Medtech Co., LtdNot yet recruitingObstructive Hypertrophic CardiomyopathyChina
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China National Center for Cardiovascular DiseasesNot yet recruitingObstructive Hypertrophic Cardiomyopathy
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Bristol-Myers SquibbNot yet recruitingObstructive Hypertrophic CardiomyopathyKorea, Republic of
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Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.RecruitingObstructive Hypertrophic CardiomyopathyChina
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Xiang WeiRecruitingNonobstructive Hypertrophic CardiomyopathyChina