Exercise Study Including Patients With Hypertrophic Cardiomyopathy

Cardiomyopathy, Hypertrophic Clinical Trial

Official title:

A Randomized Trial of Moderate Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01165749
• Other study ID #: SU-05062010-5902
• Secondary ID: 18518
• Status: Recruiting
• Phase: N/A
• First received: July 16, 2010
• Last updated: July 19, 2010
• Start date: May 2010
• Est. completion date: April 2012

Study information

• Verified date: July 2010
• Source: Stanford University
• Contact: Lisa Garrett
• Phone: (650) 736-7878
• Email: lisamariegarrett[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The long term health and cardiovascular benefits of a regular exercise program have been well-established. National guidelines recommend involvement in moderate aerobic fitness (i.e. walking, bicycling, light jogging, swimming) for patients with hypertrophic cardiomyopathy (HCM). However, data on potential benefits of recreational exercise, useful parameters for risk stratification, and methods of devising individual exercise prescriptions are completely lacking. The specific aims of this study are: 1) to devise a safe moderate intensity exercise training program in patients with HCM, and 2) to determine whether exercise training improves ability to perform activities and tasks, heart size and function, and quality of life in patients with HCM.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Ages 18 - 80 years old.

2. Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy (wall thickening) > 13 mm in any wall segment.

3. Exercise £ 30 minutes, 1 day per week for the previous 3 months.

4. Agreement to be a participant in the study protocol and willing/able to return for follow-up.

Exclusion Criteria:

1. History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia).

2. Medically refractory LV outflow tract obstruction being evaluated for septal reduction therapy.

3. Less than 3 months post septal reduction therapy (surgery or catheter based intervention).

4. Hypotensive response to exercise (> 20 mmHg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure).

5. Pregnancy.

6. ICD placement in last 3 months or scheduled.

7. Life expectancy less than 12 months.

8. Inability to exercise due to orthopedic or other non-cardiovascular limitations.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Hypertrophic
• Hypertrophy

Intervention

Behavioral:
• stop exercising

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in ability to perform activities and tasks.		4 months	No
Secondary	Improvement in heart size and function and quality of life (QOL).		4 months	No