Effect of mechanIcal circulatoRy Support ON Exercise Capacity aMong pAtieNts With Heart Failure



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:5/12/2018
Start Date:April 7, 2017
End Date:June 30, 2021
Contact:William K Cornwell, MD
Email:william.cornwell@ucdenver.edu
Phone:303-724-2085

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Effective Mechanical Circulatory Support on Exercise Capacity in Heart Failure

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.


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).
We found this trial at
1
site
13001 East 17th Place
Aurora, Colorado 80045
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Aurora, CO
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