HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy
| ISRCTN | ISRCTN87982915 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87982915 |
| ClinicalTrials.gov number | NCT01915615 |
| Secondary identifying numbers | 16889 |
- Submission date
- 22/10/2014
- Registration date
- 22/10/2014
- Last edited
- 10/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Michelle Darling
Scientific
Scientific
Suite 300, 79 TW Alexandar Drive 4401 Research Commons
Durham
NC 27709
United States of America
| Phone | +1 615 309 4200 |
|---|---|
| Michelle.Darling@iconplc.com |
Study information
| Study design | Non-randomised; Interventional; Design type: Prevention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Scientific title | HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy |
| Study acronym | HCMR Study |
| Study objectives | 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(s) | 14/SC/0190; First MREC approval date 20/05/2014 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 30/06/2014 |
| Completion date | 30/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 2750; UK Sample Size: 600 |
| Key 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. |
| Key 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 participants 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. |
| Date of first enrolment | 30/06/2014 |
| Date of final enrolment | 30/06/2016 |
Locations
Countries of recruitment
- United Kingdom
- United States of America
Study participating centre
Suite 300, 79 TW Alexandar Drive 4401 Research Commons
Durham
NC 27709
United States of America
NC 27709
United States of America
Sponsor information
University of Oxford (UK)
University/education
University/education
Research Services
Clinical Trials and Research Governance
Headley Way
Headington
Oxford
OX3 9DU
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
National Institutes of Health (NIH); Grant Codes: 1U01HL117006-01A1
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Institutos Nacionales de la Salud, US National Institutes of Health, NIH
- Location
- United States of America
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/08/2015 | 10/04/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
10/04/2019: Publication reference added.
07/03/2016: Verifying study status with principal investigator.
