View Clinical Trial (Medical Research Study)
Effectiveness of a Walking Program Modulating Cardioreparative Factors in Heart Failure
| City: |
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Nashville |
| State: |
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Tennessee |
| Zip Code: |
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37232 |
| Conditions: |
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Heart Failure |
| Purpose: |
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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 heart failure it remains insufficient in preventing the
progression of this debilitating disease. Cell based therapy has gained great strides over
the last decade, launching cellular therapy into the mix of artillery for the treatment of
chronic heart failure and coronary disease. While early pre-clinical work demonstrates that
stem cell based therapy improves heart failure the exact mechanism in which these
endothelial progenitor cells (EPC's) are recruited from the bone marrow, proliferate under
the mediation of growth factors, and migrate to the injured tissues endogenously still
remains obscured. Therefore in order for clinicians and scientist to impact heart failure
treatment, a greater understanding of the physiological changes in EPC's and other
modulators of cardioreparative process need further investigation.
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| Study Summary: |
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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 disease and heart failure. Determining how endothelial progenitor cells are
recruited, proliferate, and home to injured tissue is an important area of investigation.
Equally important is determining factors which improve EPC stimulation and efficiency such
as realistic levels of exercise and the modulation of various cardioreparative factors
(VEGF, NRG-1, and SDF-1) within heart failure patients. Since the endogenous repair
mechanism is down regulated in heart failure patients such efforts may uncover ways to tip
the balance in heart failure back to normal reparative maintenance.
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| Criteria: |
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Inclusion criteria:
1. Subjects 30-65 years old.
2. Subjects able to give Informed Consent.
3. Subjects who will give permission for collection of clinical and demographic data
from the electronic medical records.
4. 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.
5. Patient on a stable dose of statin or who can be initiated on statin therapy.
6. 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:
1. Subjects with myocardial infarction or unstable angina within the last six months.
2. Subjects with symptomatic or severe aortic stenosis.
3. Subjects with severe HTN (SBP > 180) or hypotension (SBP < 100).
4. Subjects who are pregnant.
5. Subjects who have bone marrow suppression.
6. Subjects with exercise limiting peripheral arterial disease.
7. Subjects with history of ventricular tachycardia without an implantable defibrillator
8. Subjects with decompensated diabetes (HgA1c >10).
9. Subjects with orthopedic limitations.
10. Subjects with any other clinical condition precluding regular participation in
walking exercise regimen.
11. Subjects who already participate in regular physical exercise regimen for greater
than 30 minutes a day 5 days per week.
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| NCT ID: |
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NCT00937443 |
| Primary Contact: |
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Study Director
Douglas B Saywer, MD, PhD
Vanderbilt Heart and Vascular Institute
Carrie A Geisberg, MD
Phone: 615-936-1720
Email: carrie.geisberg@vanderbilt.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Nashville, Tennessee 37232
United States
Carrie A Geisberg, MD
Phone: 615-936-1720
Email: carrie.geisberg@vanderbilt.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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