Morbidity and Mortality in Patients Diagnosed With Hypertrophic Cardiomyopathy: a CALIBER Study
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University College, London
- Enrollment
- 12,464
- Locations
- 1
- Primary Endpoint
- Rate ratios for the associations between hypertrophic cardiomyopathy and coronary heart disease not otherwise specified
Study Overview
Brief Summary
The aim of this project is to study the association of a number of demographic and cardiovascular risk factors with death, health care utilisation and systemic embolisation by examining the clinical evolution of hypertrophic cardiomyopathy in a large, community based cohort identified from linked electronic health records.
Detailed Description
Most data on hypertrophic cardiomyopathy related morbidity and mortality are derived primarily from longitudinal, observational studies based at tertiary cardiac centres. It is unclear what the main causes of morbidity and death are in the general hypertropic cardiomyopathy population (outside tertiary referral centres) and it is likely that many patients have a benign clinical course and die from non-cardiac causes.
Linkage of the Clinical Practice Research Datalink (CPRD) to the Myocardial Ischaemia National Audit Project (MINAP), Hospital Episode Statistics (HES) and Office of National Statistics (ONS), offers the opportunities to study the natural history of hypertrophic cardiomyopathy, from the time of diagnosis to the end of life, health care utilisation and to investigate the association between clinical characteristics and common clinical fatal and non-fatal outcomes.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •One year or more of follow-up in the practice prior to study entry
- •18 years or older
Exclusion Criteria
- •Unknown sex and age
Outcomes
Primary Outcomes
Rate ratios for the associations between hypertrophic cardiomyopathy and coronary heart disease not otherwise specified
Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and angina
Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and myocardial infarction
Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and cardiac arrest
Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and unstable angina
Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and abdominal aortic aneurysm
Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and ventricular arrhythmia
Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and atrial fibrillation
Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and transient ischemic attack
Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and stroke
Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and peripheral arterial disease
Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and systemic thromboembolism
Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Rate ratios for the associations between hypertrophic cardiomyopathy and heart failure
Time Frame: Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years)
Secondary Outcomes
- Rate ratios for the associations between hypertrophic cardiomyopathy and cancer(Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years))
- Rate ratios for the associations between hypertrophic cardiomyopathy and chronic obstructive pulmonary disease(Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years))
- Rate ratios for the associations between hypertrophic cardiomyopathy and liver-related(Followed for the duration of general practice registration between date of eligibility and date of administrative censoring, outcome occurrence or death (expected median of 4 years))