Clinical trial NCT02424994: Morbidity and Mortality in Patients With Hypertrophic Cardiomyopathy: a CALIBER Study
Official title: Morbidity and Mortality in Patients Diagnosed With Hypertrophic Cardiomyopathy: a CALIBER Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertrophic Cardiomyopathy
Keywords: Morbidity
Mortality
Health care utilization
Cohort
Epidemiology
Cardiovascular diseases
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Inherited Cardiac Diseases Unit, The Heart Hospital, London
First posted: 2015-04-23
Enrollment: 12464
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients registered in Clinical Practice Research Datalink (CPRD) practices

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and angina
timeFrame: 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)
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and unstable angina
timeFrame: 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)
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and myocardial infarction
timeFrame: 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)
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and coronary heart disease not otherwise specified
timeFrame: 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)
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and cardiac arrest
timeFrame: 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)
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and ventricular arrhythmia
timeFrame: 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)
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and atrial fibrillation
timeFrame: 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)
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and heart failure
timeFrame: 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)
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and transient ischemic attack
timeFrame: 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)
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and stroke
timeFrame: 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)
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and peripheral arterial disease
timeFrame: 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)
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and abdominal aortic aneurysm
timeFrame: 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)
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and systemic thromboembolism
timeFrame: 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:
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and cancer
timeFrame: 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)
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and chronic obstructive pulmonary disease
timeFrame: 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)
measure: Rate ratios for the associations between hypertrophic cardiomyopathy and liver-related
timeFrame: 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)
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Farr Institute of Health Informatics Research
Study officials:
References: