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

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ClinicalTrials.gov Identifier: NCT02424994
Recruitment Status : Unknown
Verified April 2015 by University College, London.
Recruitment status was:  Active, not recruiting
First Posted : April 23, 2015
Last Update Posted : April 23, 2015
Sponsor:
Collaborator:
Inherited Cardiac Diseases Unit, The Heart Hospital, London
Information provided by (Responsible Party):
University College, London

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.

Condition or disease Intervention/treatment
Hypertrophic Cardiomyopathy Other: No intervention

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.


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Study Type : Observational
Actual Enrollment : 12464 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Morbidity and Mortality in Patients Diagnosed With Hypertrophic Cardiomyopathy: a CALIBER Study
Study Start Date : April 2015
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015





Primary Outcome Measures :
  1. 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) ]
  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. 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) ]
  12. 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) ]
  13. 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) ]

Secondary Outcome Measures :
  1. Rate ratios for the associations between hypertrophic cardiomyopathy and cancer [ 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) ]
  2. Rate ratios for the associations between hypertrophic cardiomyopathy and chronic obstructive pulmonary 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) ]
  3. Rate ratios for the associations between hypertrophic cardiomyopathy and liver-related [ 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients registered in Clinical Practice Research Datalink (CPRD) practices
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02424994


Locations
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United Kingdom
University College London Farr Institute of Health Informatics Research
London, United Kingdom, NW1 2DA
Sponsors and Collaborators
University College, London
Inherited Cardiac Diseases Unit, The Heart Hospital, London

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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT02424994     History of Changes
Other Study ID Numbers: 13_096R
First Posted: April 23, 2015    Key Record Dates
Last Update Posted: April 23, 2015
Last Verified: April 2015
Keywords provided by University College, London:
Morbidity
Mortality
Health care utilization
Cohort
Epidemiology
Cardiovascular diseases
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Hypertrophy
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases