Status:
ACTIVE_NOT_RECRUITING
HCMR - Novel Markers of Prognosis in Hypertrophic Cardiomyopathy
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Oxford University Hospitals NHS Trust
Conditions:
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18-65 years
Brief Summary
Hypertrophic cardiomyopathy (HCM) is the most common monogenic heart disease and the most frequent cause of sudden cardiac death (SCD) in the young. It is characterized by unexplained left ventricular...
Detailed Description
2.2 Rationale Presently used risk predictors in HCM for the clinical outcomes of SCD and HF are still insufficient and limit clinical trials and institution of novel therapies in this disease. This la...
Eligibility Criteria
Inclusion
- Patients aged 18-65 with an established diagnosis of HCM defined as unexplained LVH defined as any segment ≥15mm thick, without a predisposing cause.
- Signed informed consent
Exclusion
- Prior septal myectomy or alcohol septal ablation
- Prior myocardial infarction
- Incessant ventricular arrhythmias
- Inability to lie flat,
- Contraindication to CMR including pacemakers, defibrillators, intraocular metal, certain types of intracranial aneurysm clips, severe claustrophobia,
- Stage IV/V chronic kidney disease with glomerular filtration rate \<30 ml/min,
- Diabetes mellitus with end organ damage
- Pregnant female
- Inability to provide informed consent
Key Trial Info
Start Date :
April 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
2750 Patients enrolled
Trial Details
Trial ID
NCT01915615
Start Date
April 1 2014
End Date
June 1 2025
Last Update
December 13 2024
Active Locations (44)
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1
Yale University
New Haven, Connecticut, United States, 06520
2
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
3
Johns Hopkins University
Baltimore, Maryland, United States, 21287-0409
4
Tufts Medical Center
Boston, Massachusetts, United States, 02111