HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy

Not Applicable

Completed

• Conditions: Topic: Cardiovascular disease; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular; Circulatory System; Hypertrophic cardiomyopathy

• Registration Number: ISRCTN87982915
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

2015 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/26299218 (added 10/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-22
• Study Completion: 2016-06-30
• Last Update Posted: 5 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 2750

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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> 1. Aborted SCD including appropriate intracardiac defibrillator (ICD) firing<br> 2. Need for heart transplantation<br>