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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Vanderbilt University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00937443
First received: July 9, 2009
Last updated: August 11, 2009
Last verified: August 2009
History of Changes
  Purpose
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.

Condition Intervention
Heart Failure
 Other: Physical Fitness
Biological: Walking Exercise Group

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effectiveness of a Walking Program Modulating Cardioreparative Factors in Heart Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • endothelial progenitor cells [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 50
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)
Groups/Cohorts Assigned Interventions
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 Questionnaires
Biological: Walking Exercise Group
Walking Group will increase intensity, duration, and steps of walking per week.
Other Name: Quality of Life Questionnaires

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.
  Eligibility
Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cardiac Heart Failure Patients
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00937443

Contacts
Contact: Carrie A Geisberg, MD 615-936-1720 carrie.geisberg@vanderbilt.edu

Locations
United States, Tennessee
Vanderbilt Heart and Vascular Institute Recruiting
Nashville, Tennessee, United States, 37232-8802
Contact: Carrie A Geisberg, MD    615-936-1720    carrie.geisberg@vanderbilt.edu   
Principal Investigator: Carrie A Geisberg, MD         
Sponsors and Collaborators
Vanderbilt University
Investigators
Study Director: Douglas B Saywer, MD, PhD Vanderbilt Heart and Vascular Institute
  More Information

Responsible Party: Carrie Anna Geisberg, MD, Vanderbilt Unviersity Medical Center - Vanderbilt Heart and Vascular Institute
ClinicalTrials.gov Identifier: NCT00937443     History of Changes
Other Study ID Numbers: Vanderbilt_University 
Study First Received: July 9, 2009
Last Updated: August 11, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Physical Activity
Cardiac Heart Failure
Exercise Regimen
Cardioreparative Factors

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 26, 2016