Heart FailureEPCCHFWalkNCT00937443
Effectiveness of a Walking Program Modulating Cardioreparative Factors in Heart Failure
An observational study of Heart Failure, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Physical Fitness and Walking Exercise Group
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac Heart Failure Patients
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt Heart and Vascular Institute
Nashville, Tennessee, 37232-8802
About this study
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Physical Fitness, Walking Exercise Group
- Keywords
- Physical Activity, Cardiac Heart Failure, Exercise Regimen, Cardioreparative Factors
- Medical subject headings
- Heart Failure, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical FitnessOther
Also called Quality of Life Questionnaires
Does intensity of aerobic walking exercise modify cardiac reparative factors
Walking Exercise GroupBiological
Also called Quality of Life Questionnaires
Walking Group will increase intensity, duration, and steps of walking per week.
| Study group | Role | What they receive |
|---|---|---|
| Walking Exercise Group | Walking Exercise Group versus Control Group Receives: Other: Physical Fitness; Biological: Walking Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
endothelial progenitor cells
Measured: 12 Weeks
Secondary outcomes (1)
exercise
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Douglas B Saywer, MD, PhD, Study director, Vanderbilt Heart and Vascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937443
- Sponsor's protocol ID
- Vanderbilt_University
- Acronym
- EPCCHFWalk
- Status last verified
- Mar 2017
- First submitted
- 9 Jul 2009
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Walking Program Modulating Cardioreparative Factors in Heart Failure
- ClinicalTrials.gov ID
- NCT00937443
- Acronym / sponsor ID
- EPCCHFWalk / Vanderbilt_University
- Conditions
- Heart Failure
- Keywords
- Physical Activity, Cardiac Heart Failure, Exercise Regimen, Cardioreparative Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jul 2009 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 13 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Walking Exercise Group | – | Other: Physical Fitness, Biological: Walking Exercise GroupWalking Exercise Group versus Control Group |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac Heart Failure Patients
Key inclusion criteria (8 listed)
- 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.
- Patient on a stable dose of statin or who can be initiated on statin therapy.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical FitnessAlso: Quality of Life QuestionnairesDoes intensity of aerobic walking exercise modify cardiac reparative factors | Other | Walking Exercise Group |
| Walking Exercise GroupAlso: Quality of Life QuestionnairesWalking Group will increase intensity, duration, and steps of walking per week. | Biological | Walking Exercise Group |
Primary outcome
endothelial progenitor cells
Time frame: 12 Weeks
1 secondary outcome
exercise
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Douglas B Saywer, MD, PhD study director
Vanderbilt Heart and Vascular Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
endothelial progenitor cells (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.