Effectiveness of a Walking Program Modulating Cardioreparative Factors in Heart Failure (EPCCHFWalk)
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Effectiveness of a Walking Program Modulating Cardioreparative Factors in Heart Failure|
- endothelial progenitor cells [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
- exercise [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
60 ml of blood will be used to measure baseline levels of EPC's, NRG-1, VEGF, and SDF-1. Repeat venipuncture will be done at Week 12. Approximately 60 ml of blood for the measurement of EPC's, NRG1, VEGF, and SDF-1.
|Study Start Date:||July 2009|
|Estimated Study Completion Date:||July 2011|
|Estimated Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Walking Exercise Group
Walking Exercise Group versus Control Group
Other: Physical Fitness
Does intensity of aerobic walking exercise modify cardiac reparative factors
Other Name: Quality of Life QuestionnairesBiological: Walking Exercise Group
Walking Group will increase intensity, duration, and steps of walking per week.
Other Name: Quality of Life Questionnaires
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937443
|Contact: Carrie A Geisberg, MDfirstname.lastname@example.org|
|United States, Tennessee|
|Vanderbilt Heart and Vascular Institute||Recruiting|
|Nashville, Tennessee, United States, 37232-8802|
|Contact: Carrie A Geisberg, MD 615-936-1720 email@example.com|
|Principal Investigator: Carrie A Geisberg, MD|
|Study Director:||Douglas B Saywer, MD, PhD||Vanderbilt Heart and Vascular Institute|