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

University of Colorado Denver (CU Denver)

Status: Active, not recruiting

Conditions: Heart Failure，Congestive

Study type: Observational

Funder types: Other

Identifiers

NCT03078972

16-1635

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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).

Trial design

60 participants in 3 patient groups

Advanced Heart Failure

Description:

40 patients with advanced heart failure scheduled to undergo Left Ventricular Assist Device (LVAD) insertion will be recruited for testing. Test subjects will complete testing prior to, and following LVAD implantation.

Healthy controls

Description:

10 age-matched healthy individuals will be recruited to establish normal/reference values.

Mild Heart Failure

Description:

A second control group comprised of 10 age-matched individuals will be recruited to establish normal/reference values for individuals with mild, medically managed heart failure.