NCT02994615

Brief Summary

Patients with hypertrophic cardiomyopathy are being compared to a control group. IMR will be assessed with a pressure wire. Clinical f/u at 3 months and 6 months and a 48 hour holter monitor.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

December 8, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2016

Completed
16 days until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2020

Enrollment Period

3.4 years

First QC Date

December 8, 2016

Last Update Submit

September 28, 2020

Conditions

Hypertrophic Cardiomyopathy

Keywords

Index of Microvascular ResistanceMicrovascular dysfunction

Outcome Measures

Primary Outcomes (1)

  • IMR in patients with hypertrophic cardiomyopathy (HCM) versus controls

    1 day

Secondary Outcomes (3)

  • Number of ventricular tachycardia

    6 months

  • Chest pain - Canadian Cardiovascular Society (CCS) class

    Up to 6 months

  • Shortness of breath - NYHA class

    Up to 6 months

Study Arms (2)

hypertrophic cardiomyopathy

Control

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with symptomatic hypertrophic cardiomyopathy versus controls (patients undergoing coronary angiography and FFR

You may qualify if:

  • Age 18-80
  • Already have an indication for coronary angiography
  • Previous diagnosis of hypertrophic cardiomyopathy (unless control)

You may not qualify if:

  • Fractional flow reserve found to be significant (FFR \< 0.8)
  • Already have a condition associated with or likely to be associated with an elevated IMR (diabetes, cardiac syndrome X, takotsubo cardiomyopathy, hypertensive cardiomyopathy, severe aortic stenosis, STEMI)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Canada

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve Diseases

Study Officials

  • Shahar Lavi

    London Health Sceinces Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Cardiovascular Interventional Research

Study Record Dates

First Submitted

December 8, 2016

First Posted

December 16, 2016

Study Start

January 1, 2017

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

September 30, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)