CVD Risk Profile in Children With HCM

NCT05510180 | Completed

• 1 other identifier: Pro00083230
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (3)

• CV disease risk factors

  Healthy Hearts School Program Questionnaire

  2 weeks - Visit 2

• CV disease risk behaviours

  Healthy Hearts School Program Questionnaire

  2 weeks - Visit 2

• Acquired CV disease

  Healthy Hearts School Program Questionnaire

  2 weeks - Visit 2

Secondary Outcomes (4)

• Heart healthy lifestyle barriers

  Baseline - Visit 1

• Heart healthy lifestyle barriers

  Baseline - Visit 1

• Child's perception of heart healthy lifestyle

  Baseline - Visit 1

• Parents' perception of heart healthy lifestyle

  Baseline - Visit 1

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children 10 - 19 years of age with primary hypertrophic cardiomyopathy. We are choosing to only include children with HCM as they often are told to not participate in strenuous activities b/c of the risk of sudden death. This patient population also has not been well studied and they often have other co-morbidities that may prevent exercise

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (10)

Stollery Children's Hospital

Edmonton, Alberta, T6G 2B7, Canada

Location

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Children's Hospital

Winnipeg, Manitoba, R3A 1S1, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Montreal Children's Hospital

Montreal, Quebec, H4A 3J1, Canada

Location

Centre Hospitalier de l'Université Laval

Québec, Quebec, G1V 4G2, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

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 Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2019
• First Posted: August 22, 2022
• Study Start: May 21, 2019
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)