NCT02424994

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12,464

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

April 20, 2015

Last Update Submit

April 20, 2015

Conditions

Hypertrophic Cardiomyopathy

Keywords

MorbidityMortalityHealth care utilizationCohortEpidemiologyCardiovascular diseases

Outcome Measures

Primary Outcomes (13)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

  • 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)

Secondary Outcomes (3)

  • 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)

Interventions

No interventionOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients registered in Clinical Practice Research Datalink (CPRD) practices

You may qualify if:

  • One year or more of follow-up in the practice prior to study entry
  • years or older

You may not qualify if:

  • Unknown sex and age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London Farr Institute of Health Informatics Research

London, NW1 2DA, United Kingdom

Location

MeSH Terms

Conditions

Cardiomyopathy, HypertrophicPatient Acceptance of Health CareCardiovascular Diseases

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2015

First Posted

April 23, 2015

Study Start

April 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 23, 2015

Record last verified: 2015-04

Locations

GB(1)