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Clinical Trials/NCT02424994
NCT02424994
Unknown
Not Applicable

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

University College, London1 site in 1 country12,464 target enrollmentApril 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertrophic Cardiomyopathy
Sponsor
University College, London
Enrollment
12464
Locations
1
Primary Endpoint
Rate ratios for the associations between hypertrophic cardiomyopathy and coronary heart disease not otherwise specified
Last Updated
11 years ago

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
December 2015
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

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))

Study Sites (1)

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