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

Active, not recruiting

• Conditions: Heart Failure，Congestive

• Registration Number: NCT03078972
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-14
• Study Start: 2017-04-07
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-17
• Last Update Posted: 2023-05-18
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in the sympathetic neural response.	4 weeks prior to implantation and 6 months post implantation.	The primary outcome will be the difference in the muscle sympathetic neural response (MSNA) to handgrip and post-exercise circulatory arrest (PECA) before and after Continuous-flow left ventricular assist device (CF-LVAD) insertion
Change in VO2.	4 weeks prior to implantation and 6 months post implantation.	The primary outcome will be the change in the VO2 (maximum rate of oxygen consumption) before and after CF-LVAD insertion.

Secondary Outcome Measures

Name	Time	Method
Changes in the hemodynamic response.	4 weeks prior to implantation and 6 months post implantation.	This outcome will evaluate any difference in the hemodynamic response (heart rate and blood pressure) to handgrip and PECA before and after CF-LVAD
Oxygen uptake and utilization	4 weeks prior to implantation and 6 months post implantation.	Cerebral and musculoskeletal oxygen uptake by near-infrared spectroscopy
VO2 relationship and ventilatory threshold (1)	4 weeks prior to implantation and 6 months post implantation.	Cardiac output (Qc): VO2 relationship and ventilatory threshold before and after CF-LVAD insertion.
VO2 relationship and ventilatory threshold (2).	4 weeks prior to implantation and 6 months post implantation.	Determinants of Qc after CF-LVAD insertion (ie, contribution from device v. contribution from left ventricle).
VO2 relationship and ventilatory threshold (4).	4 weeks prior to implantation and 6 months post implantation.	Bloodflow to the periphery, as measured by transcranial Doppler to assess brain bloodflow during exercise/activity.
VO2 relationship and ventilatory threshold (3).	4 weeks prior to implantation and 6 months post implantation.	Qc, VO2, ventilatory threshold and exercise capacity at increased pump speed.

Trial Locations

Locations (1)

University of Colorado Snschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States