A Study to Compare Post-exercise Treadmill versus Supine Bicycle Exercise Left Ventricular Outflow Tract Gradients Assessed by Echocardiography in Hypertrophic Cardiomyopathy
Overview
Tab Title Description
Study type
InterventionalDescribes 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: 13-001000
Sponsor Protocol Number: 13-001000
About this study
Exercise testing is routinely utilized in the evaluation of patient’s with hypertrophic cardiomyopathy to assess exercise capacity and also to evaluate the presence and severity of obstruction with an echocardiogram. Identifying significant obstruction is important in order to determine who could gain benefit from more invasive therapies like surgery.
There are several different exercise protocols available but it is not known which is the best method to assess the presence and severity of obstruction in hypertrophic cardiomyopathy. The purpose of this study is to determine which exercise protocol (supine bike or exercise treadmill) is better in these regards.
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 with a diagnosis of hypertrophic cardiomyopathy (≥15mm wall thickness, non-dilated left ventricle, absence of a secondary cause of hypertrophy)
- HCM patients referred for and capable of exercise testing
- Patients who consent to participate in study
Exclusion Criteria:
- Patients who decline to participate in study
- Inadequate image quality
- Paced rhythm
- Patient unable to exercise due to other comorbidities
- Severe resting LVOT gradients (>100mmHg)
- Severe symptoms (syncope, dyspnea, angina) / decompensated heart failure
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 Steve Ommen, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available