Status:
COMPLETED
Exercise Training in Heart Failure: Changes in Cardiac Structure and Function
Lead Sponsor:
VA Office of Research and Development
Conditions:
Heart Failure
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This is a research study being conducted to better understand the impact of exercise training on changes on the structure and function of the heart. Exercise training in patients with heart failure ha...
Detailed Description
Prevalence of systolic heart failure (HF) is high among the growing population of older adults. Progressive cardiac remodeling and deteriorating cardiac output have been implicated as key factors unde...
Eligibility Criteria
Inclusion
- New York Heart Association (NYHA) class II or III for the previous three months despite a minimum of 6 weeks of optimal treatment.
- Age \>50 years.
- Left Ventricular Ejection Fraction (LVEF)\<45% (by echocardiogram or radionucleotide imaging study within 6 months of enrollment). If a patient has initiated or received any therapy that might improve the ejection fraction, the qualifying EF must be assessed after the patient is on a stable dose of these therapies. Additionally the LVEF of \<45% will be confirmed with a brief echocardiogram prior to randomization. If LVEF is not 45%, the patient will not be enrolled in to the study.
- Optimal therapy according to the American Heart Association (AHA)/American College of Cardiology (ACC) and the Heart Failure Society of America (HFSA) Heart Failure (HF) guidelines, including treatment with an angiotensin-converting-enzyme (ACE) Inhibitor (or an angiotensin receptor blocker) and beta-blocker therapy (for at least 6 weeks), or have documented reason for variation, including medication intolerance, contraindication, patient preference, or personal physician's judgment.
- In addition to the above we have now added patients with heart failure with preserved ejection fraction (similar to the parent study )pending Institutional Review Board (IRB) review.
Exclusion
- Major cardiovascular event or procedure within the prior 6 weeks.
- Dementia.
- Severe chronic obstructive pulmonary disease (COPD) (FEV1\<50%), peripheral vascular disease (PVD), and/or Anemia.
- End-stage malignancy.
- Severe valvular heart disease.
- Orthopedic exercise limitation.
- Women who are pregnant, breastfeeding, or likely to become pregnant within the next 6 months.
- Psychiatric hospitalization within the last 3 months.
- Implantable Cardioverter Defibrillator (ICD) device with heart rate limits that prohibit exercise assessments or exercise training. Referring physicians will be provided with an opportunity to reprogram devices so that patients can participate.
- Chronic ethyl alcohol (ETOH) or drug dependency.
Key Trial Info
Start Date :
June 6 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT02275819
Start Date
June 6 2016
End Date
April 23 2019
Last Update
March 8 2021
Active Locations (1)
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1
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130