A Study to Develop a Hypertrophic Cardiomyopathy Registry
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-003835
NCT ID: NCT01915615
Sponsor Protocol Number: 14-003835
About this study
The purpose of this study is to use data mining methods to identify demographic, clinical, and new CMR, genetic and biomarker variables to then develop a predictive risk assessment model to score a patient's combination of factors for HCM, and establish the evidence base to later enable clinical trial design to reduce the morbidity and mortality of HCM in a cost-effective manner.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients aged 18-65.
- Having an established diagnosis of Hypertrophic Cardiomyopathy defined as unexplained Left Ventricular Hypertrophy defined as any segment ≥ 15mm thick, without a predisposing cause.
- Signed informed consent.
Exclusion Criteria:
- 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.
Eligibility last updated 10/19/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Eric Williamson, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available