Heart Failure Clinical Trial
Effect of mechanIcal circulatoRy Support ON Exercise Capacity aMong pAtieNts With Heart Failure
Summary
This study will evaluate how the cardiovascular system interacts with mechanical hearts to provide blood flow to the body during exercise. Two aims are proposed: 1) to determine the impact of a mechanical heart on exercise pressor reflexes in heart failure patients; and 2) to define the primary determinant(s) of exercise capacity in heart failure patients before and after device implantation.
Eligibility Criteria
Advanced Heart Failure-
Inclusion Criteria:
Individuals with severely reduced left ventricular systolic function that are scheduled to undergo LVAD insertion
Exclusion Criteria:
uncontrolled diabetes with peripheral neuropathy (interferes with acquisition of MSNA signal)
Individuals with clinical right ventricular failure, defined as moderate-severely reduced RV systolic function on echocardiography, or clinical evidence of RV failure (elevated jugular venous pressures, significant peripheral edema)
Individuals with moderate-severe preexisting aortic insufficiency, as these patients will typically undergo a Park stitch at time of CF-LVAD insertion to permanently close the aortic valve and prevent worsening aortic insufficiency; and
Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease)
Mild Heart Failure -
Inclusion Criteria:
Individuals with medically managed left ventricular systolic function that are NOT scheduled to undergo LVAD insertion
HF patients with ejection fraction <35-40%
Exclusion Criteria:
Individuals requiring systemic anticoagulation with vitamin-K antagonists or new/direct oral anticoagulants ("NOAC"/"DOAC")
Disorders that adversely influence exercise ability (e.g. arthritis, peripheral vascular disease, pulmonary disease)
History of uncontrolled arrhythmias (e.g. ventricular tachycardia or nonsustained ventricular tachycardia).
Healthy Controls -
Inclusion Criteria:
- Persons without a past medical history of cardiovascular disease or related disease (e.g. hypertension, diabetes, peripheral vascular disease, arrhythmias, stroke/transient ischemic attack) and are not taking any cardiac-related medications (e.g. antihypertensive medications)
Exclusion Criteria:
Individuals requiring systemic anticoagulation with vitamin-K antagonists or new/direct oral anticoagulants ("NOAC"/"DOAC")
Disorders that adversely influence exercise ability (e.g. arthritis, peripheral ascular disease).
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There is 1 Location for this study
Aurora Colorado, 80045, United States
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