- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01165749
Exercise Study Including Patients With Hypertrophic Cardiomyopathy
July 19, 2010 updated by: Stanford University
A Randomized Trial of Moderate Intensity Exercise Training in Patients With Hypertrophic Cardiomyopathy
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lisa Garrett
- Phone Number: (650) 736-7878
- Email: lisamariegarrett@gmail.com
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Recruiting
- Stanford University School of Medicine
-
Contact:
- Lisa Garrett
- Phone Number: 650-736-7878
- Email: lisamariegarrett@gmail.com
-
Contact:
- Terra Coakley
- Phone Number: (650) 725-6186
- Email: tcoakley@stanford.edu
-
Principal Investigator:
- Dr. Euan Ashley MRCP, DPhil
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients diagnosed with hypertrophic cardiomyopathy
Description
Inclusion Criteria:
- Ages 18 - 80 years old.
- Diagnosis of hypertrophic cardiomyopathy, defined by the presence of unexplained left-ventricular hypertrophy (wall thickening) > 13 mm in any wall segment.
- Exercise £ 30 minutes, 1 day per week for the previous 3 months.
- Agreement to be a participant in the study protocol and willing/able to return for follow-up.
Exclusion Criteria:
- History of exercise-induced syncope or arrhythmias (ventricular tachycardia or non-sustained ventricular tachycardia).
- Medically refractory LV outflow tract obstruction being evaluated for septal reduction therapy.
- Less than 3 months post septal reduction therapy (surgery or catheter based intervention).
- Hypotensive response to exercise (> 20 mmHg drop in systolic blood pressure from peak blood pressure to post exercise blood pressure).
- Pregnancy.
- ICD placement in last 3 months or scheduled.
- Life expectancy less than 12 months.
- Inability to exercise due to orthopedic or other non-cardiovascular limitations.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in ability to perform activities and tasks.
Time Frame: 4 months
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improvement in heart size and function and quality of life (QOL).
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Dr. Euan Ashley MRCP, DPhil, Stanford University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
April 1, 2012
Study Registration Dates
First Submitted
July 16, 2010
First Submitted That Met QC Criteria
July 19, 2010
First Posted (Estimate)
July 20, 2010
Study Record Updates
Last Update Posted (Estimate)
July 20, 2010
Last Update Submitted That Met QC Criteria
July 19, 2010
Last Verified
July 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-05062010-5902
- 18518
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiomyopathy, Hypertrophic
-
French Cardiology SocietyCompleted1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy | 2- Obstructive Hypertrophic Cardiomyopathy | 3- Non Obstructive Hypertrophic CardiomyopathyFrance
-
Montreal Heart InstituteCanadian Institutes of Health Research (CIHR)Enrolling by invitationCardiomyopathies | Hypertrophic Cardiomyopathy | Hypertrophic Obstructive Cardiomyopathy | Familial Hypertrophic CardiomyopathyCanada
-
University of Sao PauloCompletedNon-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyBrazil
-
Bristol-Myers SquibbActive, not recruitingHypertrophic Cardiomyopathy | Non-obstructive Hypertrophic Cardiomyopathy | Obstructive Hypertrophic CardiomyopathyDenmark, United States, Belgium, Czechia, France, Germany, Israel, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom
-
Yonsei UniversityCompletedFamilial Hypertrophic CardiomyopathyKorea, Republic of
-
Hangzhou Valgen Medtech Co., LtdNot yet recruitingObstructive Hypertrophic CardiomyopathyChina
-
China National Center for Cardiovascular DiseasesNot yet recruitingObstructive Hypertrophic Cardiomyopathy
-
Bristol-Myers SquibbNot yet recruitingObstructive Hypertrophic CardiomyopathyKorea, Republic of
-
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.RecruitingObstructive Hypertrophic CardiomyopathyChina
-
Xiang WeiRecruitingNonobstructive Hypertrophic CardiomyopathyChina
Clinical Trials on stop exercising
-
Universiteit AntwerpenUniversity of Southern Denmark; University of Malaga; Rotterdam University of...Completed
-
Cairo UniversityRecruitingCognitive Impairment | Subclinical hypothyroïdismEgypt
-
Roswell Park Cancer InstituteCompletedBreast Cancer | ArthralgiaUnited States
-
University of ArizonaRecruitingNeoplasms | Exercise | Caregiver Burden | Prostate CancerUnited States
-
South Valley UniversityCompleted
-
Mansoura UniversityRecruitingDIAPHRAGM -Ultrasound -Weaning -Mechanical VentilationEgypt
-
University Hospital, Basel, SwitzerlandCompleted
-
Hugo de Luca CorreaFederal University of São Paulo; Catholic University of BrasíliaCompletedQuality of Life | Inflammation | Muscle Weakness | Chronic Kidney Failure | Solid Organ Transplant Rejection
-
Universiteit AntwerpenUniversity of Southern Denmark; University of Malaga; Rotterdam University of...CompletedShoulder Impingement SyndromeBelgium