Status:
COMPLETED
Effectiveness of a Walking Program Modulating Cardioreparative Factors in Heart Failure
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Heart Failure
Eligibility:
All Genders
30-65 years
Brief Summary
The incidence of heart failure grows as the population continues to age. Heart failure incidence approaches 10 per 1,000 persons after the age of 65. Although pharmacotherapy improves the treatment of...
Detailed Description
Heart failure remains a devastating progressive chronic disease in which pharmacotherapy is not often sufficient. Although cell based therapy is gaining publicity in the treatment of coronary artery d...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects 30-65 years old.
- Subjects able to give Informed Consent.
- Subjects who will give permission for collection of clinical and demographic data from the electronic medical records.
- Subjects with symptomatic ischemic or non-ischemic heart failure in a stable condition with New York Heart Association class II-III for at least the last 3 months before study enrollment.
- Left ventricular ejection fraction (LVEF) \< 40%.
- Peak volume of oxygen utilization (peak VO2) of \< 25 ml/kg/min.
- Patient on a stable dose of statin or who can be initiated on statin therapy.
- Subjects with ischemic cardiomyopathy must have had either a negative stress test within the last 6 months or a cardiac catheterization within the last year confirming stable disease.
- Exclusion criteria:
- Subjects with myocardial infarction or unstable angina within the last six months.
- Subjects with symptomatic or severe aortic stenosis.
- Subjects with severe HTN (SBP \> 180) or hypotension (SBP \< 100).
- Subjects who are pregnant.
- Subjects who have bone marrow suppression.
- Subjects with exercise limiting peripheral arterial disease.
- Subjects with history of ventricular tachycardia without an implantable defibrillator
- Subjects with decompensated diabetes (HgA1c \>10).
- Subjects with orthopedic limitations.
- Subjects with any other clinical condition precluding regular participation in walking exercise regimen.
- Subjects who already participate in regular physical exercise regimen for greater than 30 minutes a day 5 days per week.
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00937443
Start Date
July 1 2009
End Date
January 1 2014
Last Update
April 4 2017
Active Locations (1)
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1
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, United States, 37232-8802