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

Hypertrophic Cardiomyopathy Clinical Trial

— HCM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02424994
• Other study ID #: 13_096R
• Status: Active, not recruiting
• Phase: N/A
• First received: April 20, 2015
• Last updated: April 20, 2015
• Start date: April 2015
• Est. completion date: December 2015

Study information

• Verified date: April 2015
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: CALIBER Scientific Oversight CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 12464
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophic Cardiomyopathy
• Hypertrophy

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
United Kingdom	University College London Farr Institute of Health Informatics Research	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Inherited Cardiac Diseases Unit, The Heart Hospital, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate ratios for the associations between hypertrophic cardiomyopathy and angina		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)	No
Primary	Rate ratios for the associations between hypertrophic cardiomyopathy and unstable angina		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)	No
Primary	Rate ratios for the associations between hypertrophic cardiomyopathy and myocardial infarction		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)	No
Primary	Rate ratios for the associations between hypertrophic cardiomyopathy and coronary heart disease not otherwise specified		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)	No
Primary	Rate ratios for the associations between hypertrophic cardiomyopathy and cardiac arrest		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)	No
Primary	Rate ratios for the associations between hypertrophic cardiomyopathy and ventricular arrhythmia		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)	No
Primary	Rate ratios for the associations between hypertrophic cardiomyopathy and atrial fibrillation		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)	No
Primary	Rate ratios for the associations between hypertrophic cardiomyopathy and heart failure		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)	No
Primary	Rate ratios for the associations between hypertrophic cardiomyopathy and transient ischemic attack		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)	No
Primary	Rate ratios for the associations between hypertrophic cardiomyopathy and stroke		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)	No
Primary	Rate ratios for the associations between hypertrophic cardiomyopathy and peripheral arterial 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)	No
Primary	Rate ratios for the associations between hypertrophic cardiomyopathy and abdominal aortic aneurysm		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)	No
Primary	Rate ratios for the associations between hypertrophic cardiomyopathy and systemic thromboembolism		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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No