Exercise Training in Heart Failure: Changes in Cardiac Structure and Function
Completed · Not applicable
Conditions studied: Heart Failure
In brief
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 has been shown to be beneficial at decreasing symptoms of heart failure and improving overall functional capacity or capacity to exercise. However the mechanisms responsible for this are still unclear. This study will look specifically at how exercise creates changes within the hearts filling ability, the hearts pumping strength as well as the hearts ability to rebuild.
Key facts
- Study ID
- NCT02275819
- Run by
- VA Office of Research and Development
- People needed
- 11
- Starts
- 2016-06-06
- Expected to finish
- 2019-04-23
- Last updated by the study team
- 2021-03-08
Who can join
Age: 50 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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