Effectiveness of a Walking Program Modulating Cardioreparative Factors in Heart Failure

Completed

• Conditions: Heart Failure
• Interventions: Other: Physical Fitness; Biological: Walking Exercise Group

• Registration Number: NCT00937443
• Lead Sponsor: Vanderbilt University Medical Center

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 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.

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 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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-30
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Walking Exercise Group	Physical Fitness	Walking Exercise Group versus Control Group
Walking Exercise Group	Walking Exercise Group	Walking Exercise Group versus Control Group

Primary Outcome Measures

Name	Time	Method
endothelial progenitor cells	12 Weeks

Secondary Outcome Measures

Name	Time	Method
exercise	12 Months

Trial Locations

Locations (1)

Vanderbilt Heart and Vascular Institute; 🇺🇸 Nashville, Tennessee, United States