Hypertrophic CardiomyopathyNCT05510180
CVD Risk Profile in Children With HCM
An observational study of Hypertrophic Cardiomyopathy, run by University of Alberta at 10 sites in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- How many people
- 56 participants
- Where
- 10 sitesCanada
- Study dates
- 21 May 2019to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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 -
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Canada10 sites
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Montreal Children's Hospital
Montreal, Quebec, H4A 3J1
Centre Hospitalier de l'Université Laval
Québec, Quebec, G1V 4G2
Jim Pattison Children's Hospital
Saskatoon, Saskatchewan, S7N 0W8
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
Hospital for Sick Children
Toronto, Ontario, M5G 1X8
BC Children's Hospital
Vancouver, British Columbia, V6H 3N1
Children's Hospital
Winnipeg, Manitoba, R3A 1S1
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertrophic Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What is being measured
The primary outcome is the main question the study is designed to answer.
CV disease risk factors
Healthy Hearts School Program Questionnaire
Measured: 2 weeks - Visit 2
CV disease risk behaviours
Healthy Hearts School Program Questionnaire
Measured: 2 weeks - Visit 2
Acquired CV disease
Healthy Hearts School Program Questionnaire
Measured: 2 weeks - Visit 2
Secondary outcomes (4)
Heart healthy lifestyle barriers
Self-Efficacy for Exercise Scale
Measured: Baseline - Visit 1
Heart healthy lifestyle barriers
PedsQL (Pediatric Quality of Life Inventory and Pediatric Quality of Life Inventory: Cardiac Module)
Measured: Baseline - Visit 1
Child's perception of heart healthy lifestyle
Habitual Activity Estimation Scale (HAES)
Measured: Baseline - Visit 1
Parents' perception of heart healthy lifestyle
Habitual Activity Estimation Scale (HAES)
Measured: Baseline - Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start21 May 2019
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510180
- Sponsor's protocol ID
- Pro00083230
- Status last verified
- May 2023
- First submitted
- 5 Mar 2019
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Disease Risk Profile in Children With Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT05510180
- Acronym / sponsor ID
- Pro00083230
- Conditions
- Hypertrophic Cardiomyopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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 -
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CV disease risk factors
Time frame: 2 weeks - Visit 2
Healthy Hearts School Program Questionnaire
CV disease risk behaviours
Time frame: 2 weeks - Visit 2
Healthy Hearts School Program Questionnaire
Acquired CV disease
Time frame: 2 weeks - Visit 2
Healthy Hearts School Program Questionnaire
4 secondary outcomes
Heart healthy lifestyle barriers
Time frame: Baseline - Visit 1
Heart healthy lifestyle barriers
Time frame: Baseline - Visit 1
Child's perception of heart healthy lifestyle
Time frame: Baseline - Visit 1
Parents' perception of heart healthy lifestyle
Time frame: Baseline - Visit 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertrophic Cardiomyopathy, run by University of Alberta at 10 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CV disease risk factors (time frame: 2 weeks - Visit 2). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023; AzTrials last refreshed its copy on 1 Nov 2026.