Effectiveness of a Walking Program Modulating Cardioreparative Factors in Heart Failure

NCT00937443 | Completed

• 1 other identifier: Vanderbilt_University
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Physical Activity; Cardiac Heart Failure; Exercise Regimen; Cardioreparative Factors

Outcome Measures

Primary Outcomes (1)

• endothelial progenitor cells

  12 Weeks

Secondary Outcomes (1)

• exercise

  12 Months

Study Arms (1)

Walking Exercise Group

Walking Exercise Group versus Control Group

Other: Physical Fitness; Biological: Walking Exercise Group

Interventions

Physical Fitness OTHER

Does intensity of aerobic walking exercise modify cardiac reparative factors

Also known as: Quality of Life Questionnaires

Walking Exercise Group

Walking Exercise Group BIOLOGICAL

Walking Group will increase intensity, duration, and steps of walking per week.

Also known as: Quality of Life Questionnaires

Walking Exercise Group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cardiac Heart Failure Patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt Heart and Vascular Institute

Nashville, Tennessee, 37232-8802, United States

Location

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.

MeSH Terms

Conditions

Heart Failure; Motor Activity

Interventions

Physical Fitness

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Health; Population Characteristics

Study Officials

• Douglas B Saywer, MD, PhD

  Vanderbilt Heart and Vascular Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2009
• First Posted: July 13, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

US (1)