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Morbidity and Mortality in Patients With Hypertrophic Cardiomyopathy: a CALIBER Study

Morbidity and Mortality in Patients Diagnosed With Hypertrophic Cardiomyopathy: a CALIBER Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02424994
Acronym
HCM
Enrollment
12464
Registered
2015-04-23
Start date
2015-04-30
Completion date
2015-12-31
Last updated
2015-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertrophic Cardiomyopathy

Keywords

Morbidity, Mortality, Health care utilization, Cohort, Epidemiology, Cardiovascular diseases

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.

Interventions

OTHERNo intervention

Sponsors

Inherited Cardiac Diseases Unit, The Heart Hospital, London
CollaboratorUNKNOWN
University College, London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Rate ratios for the associations between hypertrophic cardiomyopathy and systemic thromboembolismFollowed 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 strokeFollowed 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 diseaseFollowed 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 aneurysmFollowed 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 anginaFollowed 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 anginaFollowed 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 infarctionFollowed 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 coronary heart disease not otherwise specifiedFollowed 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 arrestFollowed 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 arrhythmiaFollowed 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 fibrillationFollowed 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 failureFollowed 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 attackFollowed 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

MeasureTime frame
Rate ratios for the associations between hypertrophic cardiomyopathy and chronic obstructive pulmonary diseaseFollowed 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-relatedFollowed 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 cancerFollowed 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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026