Condition category
Circulatory System
Date applied
22/10/2014
Date assigned
22/10/2014
Last edited
07/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Michelle Darling

ORCID ID

Contact details

Suite 300
79 TW Alexandar Drive 4401 Research Commons
Durham
NC 27709
United States of America
+1 615 309 4200
Michelle.Darling@iconplc.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01915615

Protocol/serial number

16889

Study information

Scientific title

HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy

Acronym

HCMR Study

Study hypothesis

Hypertrophic cardiomyopathy (HCM) is a condition, mostly inherited, in which the heart muscle becomes thickened. People with this condition usually do not have symptoms. However, in some people with this condition, there is a risk of developing complications such as failure of the heart to pump blood and sudden death. Currently doctors do not know much about why some people develop these complications. The purpose of this study is to find ways of predicting the risk of developing these problems, so that appropriate treatment can be given. This study will carry out a careful and thorough assessment of people with HCM using new sophisticated tests to identify markers that are associated with these complications. This information will help doctors to identify people with HCM who are at higher risks of developing complications in the future as a result of the disease.

The University of Oxford, UK, in collaboration with the University of Virginia, US are organising this research. The research taking place in Europe is the responsibility of the University of Oxford, while that taking place in North America is the responsibility of the University of Virginia. There will be 40 sites involved in this study as follow:

1. UK: 11 sites
2. Germany: 3 sites
3. Italy: 4 sites
4. The Netherlands: 2 sites
5. USA: 17 sites
6. Canada: 3 sites

Ethics approval

14/SC/0190; First MREC approval date 20/05/2014

Study design

Non-randomised; Interventional; Design type: Prevention

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular

Intervention

1. Cannula and venous blood sampling (~80mls);
2. Medical history and physical examination
3. Echocardiogram. Ultrasound images of the heart using standard clinical scanners. This will only be done if there is no echocardiogram done in the last 12 months.
4. Electrocardiogram (ECG). Attaching surface electrodes on the chest to monitor electrical properties of the heart. This will only be done if there is no ECG done in the last 12 months.
5. Cardiovascular magnetic resonance (CMR) imaging of the heart acquired using standard clinical scanners.
6. Gadolinium contrast dye injected via a cannula in the participant's arm to enhance images during MRI scans.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The composite of cardiac death due to sudden cardiac death (SCD) and congestive heart failure (CHF)

Secondary outcome measures

1. Aborted SCD including appropriate intracardiac defibrillator (ICD) firing
2. Need for heart transplantation

Overall trial start date

30/06/2014

Overall trial end date

30/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male or Female, aged 18-65
2. Established diagnosis of HCM defined as unexplained LVH defined as any segment = 15mm thick
3. Signed informed consent
4. Able (in the investigator's opinion) and willing to comply with all study requirements;

1300-1500 recruited in the Europe, of which 600-1000 recruited in the UK. A further 1250 will be recruited in the US and Canada and these sites have sought and received separate IRB approvals in the US and Canada.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 2750; UK Sample Size: 600

Participant exclusion criteria

1. Uncontrolled hypertension as judged by the investigator
2. Atrial fibrillation at time of enrollment
3. Angiographically documented >50% coronary stenosis
4. Prior septal myectomy or alcohol septal ablation
5. Prior myocardial infarction
6. Incessant ventricular arrhythmias
7. Diabetes with end organ damage
8. Stage IV/V chronic kidney disease (eGFR <30ml/min)
9. Inability to tolerate MRI scanning (severe claustrophobia, inability to lie flat)
10. Contraindications to CMR imaging (implantable devices or other metal implants, cranial aneurysm clips, metallic ocular foreign bodies, hypersensitivity to gadolinium)
11. Female participant who is pregnant or lactating
12. Malignancy or other serious medical condition expected to limit lifespan <5 years
13. Any other significant disease or disorder which, in the opinion of the investigator, might influence the participant’s ability to participate in the study.
14. Involvement in other studies thought to compromise resulting study data or the health of the participant.
15. Inability to give informed consent.

Recruitment start date

30/06/2014

Recruitment end date

30/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Suite 300, 79 TW Alexandar Drive 4401 Research Commons
Durham
NC 27709
United States of America

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Research Services
Clinical Trials and Research Governance
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institutes of Health (NIH); Grant Codes: 1U01HL117006-01A1

Alternative name(s)

NIH

Funding Body Type

government organisation

Funding Body Subtype

federal/national government

Location

United States of America

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

07/03/2016: Verifying study status with principal investigator.