HCMR - Novel Predictors of Outcome in Hypertrophic Cardiomyopathy

niversity of Oxford (UK)0 个研究点目标入组 2,750 人开始时间: 2014年10月22日最近更新: 2019年5月5日

适应症

试验速览

•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.

•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.

发起方

niversity of Oxford (UK)