Status:
COMPLETED
High Intensity Exercise for Increasing Fitness in Patients With Hypertrophic Cardiomyopathy
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Biotronik SE & Co. KG
American College of Sports Medicine
Conditions:
Hypertrophic Cardiomyopathy
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
Although current clinical guidelines stipulate that patients with hypertrophic cardiomyopathy should not partake in high intensity exercise (HIE) or competitive sport due to safety concerns, there is ...
Detailed Description
Regular exercise reduces the risk of all-cause and cardiovascular mortality in the general population. Specifically, higher cardiorespiratory fitness is associated with a 10 - 20 % reduction in mortal...
Eligibility Criteria
Inclusion
- Male and female patients aged 18 - 80 years old
- Diagnosed HCM defined by the presence of unexplained left-ventricular hypertrophy with end-diastolic wall thickness ≥ 15 mm on 2D echocardiography or wall thickness between 13 and 15 mm along with at least one other piece of evidence of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result.
Exclusion
- A history of exercise-induced syncope or arrhythmias (ventricular tachycardia; sustained or non-sustained)
- Left ventricular outflow obstruction (≥ 50 mm Hg at rest)
- Less than 3 months post septal reduction therapy (surgery or catheter based intervention)
- Pregnancy
- Worsening clinical status or advanced heart failure (New York Heart Association class IV symptoms)
- A hypotensive responsive to exercise (an increase in exercise systolic BP throughout the exercise test of \< 20mmHg compared with resting values, or an initial increase in systolic BP \> 20mmHg with a subsequent fall by peak exercise of \> 20mmHg, or a continuous decrease in systolic BP throughout the test of \> 20mmHg, compared with baseline BP)
- Left ventricular systolic dysfunction (left ventricular ejection fraction \< 55 % by echocardiography)
- Coronary artery disease as evidenced by prior myocardial infarction or angina
- Cerebrovascular disease as evidenced by prior transient ischemic attack or stroke
- A chronic orthopaedic injury which limits the ability to exercise
- Subjects unable to speak English will not be recruited because of the complex experimental studies and the need for precise communication between the volunteers and the research staff to ensure safety.
Key Trial Info
Start Date :
January 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2022
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03335332
Start Date
January 31 2018
End Date
December 20 2022
Last Update
February 28 2023
Active Locations (1)
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1
The Institute for Exercise and Environmental Medicine
Dallas, Texas, United States, 75231