Effective Mechanical Circulatory Support on Exercise Capacity in Heart Failure
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure，Congestive
- Sponsor
- University of Colorado, Denver
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Changes in the sympathetic neural response.
- Status
- Active, Not Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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")
Outcomes
Primary Outcomes
Changes in the sympathetic neural response.
Time Frame: 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.
Time Frame: 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 Outcomes
- Changes in the hemodynamic response.(4 weeks prior to implantation and 6 months post implantation.)
- Oxygen uptake and utilization(4 weeks prior to implantation and 6 months post implantation.)
- VO2 relationship and ventilatory threshold (1)(4 weeks prior to implantation and 6 months post implantation.)
- VO2 relationship and ventilatory threshold (2).(4 weeks prior to implantation and 6 months post implantation.)
- VO2 relationship and ventilatory threshold (4).(4 weeks prior to implantation and 6 months post implantation.)
- VO2 relationship and ventilatory threshold (3).(4 weeks prior to implantation and 6 months post implantation.)