Effectiveness of a Walking Program Modulating Cardioreparative Factors in Heart Failure (EPCCHFWalk)

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Physical Fitness; Biological: Walking Exercise Group

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 Type: Observational
• Enrollment (Actual): 9

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-8802
      • Vanderbilt Heart and Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Cardiac Heart Failure Patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Walking Exercise Group; Walking Exercise Group versus Control Group	Other: Physical Fitness; Does intensity of aerobic walking exercise modify cardiac reparative factors; Other Names: Quality of Life Questionnaires; Biological: Walking Exercise Group; Walking Group will increase intensity, duration, and steps of walking per week.; Other Names: Quality of Life Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
endothelial progenitor cells	12 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
exercise	12 Months

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Study Director: Douglas B Saywer, MD, PhD, Vanderbilt Heart and Vascular Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: July 9, 2009
• First Submitted That Met QC Criteria: July 10, 2009
• First Posted (Estimate): July 13, 2009

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: March 30, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Physical Activity; Exercise Regimen; Cardiac Heart Failure; Cardioreparative Factors
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Vanderbilt_University