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

March 30, 2017 updated by: Vanderbilt University Medical Center
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
endothelial progenitor cells
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
exercise
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vanderbilt University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Douglas B Saywer, MD, PhD, Vanderbilt Heart and Vascular Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 4, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Vanderbilt_University

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings