Clinical trial NCT03078972: Effect of mechanIcal circulatoRy Support ON Exercise Capacity aMong pAtieNts With Heart Failure
Official title: Effective Mechanical Circulatory Support on Exercise Capacity in Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure，Congestive
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 40 - HF patients with advanced heart failure who are scheduled to undergo LVAD insertion (Advanced Heart Failure)

10 - HF patients with mild heart failure who are not scheduled to undergo LVAD insertion, to serve as first control group (Mild Heart Failure)

10 - Age-matched healthy individuals, with no past medical history, to serve as a second control group (Healthy Controls)

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.


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).

Primary outcomes:
measure: Changes in the sympathetic neural response.
timeFrame: 4 weeks prior to implantation and 6 months post implantation.
measure: Change in VO2.
timeFrame: 4 weeks prior to implantation and 6 months post implantation.
Secondary outcomes:
measure: Changes in the hemodynamic response.
timeFrame: 4 weeks prior to implantation and 6 months post implantation.
measure: VO2 relationship and ventilatory threshold (1)
timeFrame: 4 weeks prior to implantation and 6 months post implantation.
measure: VO2 relationship and ventilatory threshold (2).
timeFrame: 4 weeks prior to implantation and 6 months post implantation.
measure: VO2 relationship and ventilatory threshold (3).
timeFrame: 4 weeks prior to implantation and 6 months post implantation.
measure: VO2 relationship and ventilatory threshold (4).
timeFrame: 4 weeks prior to implantation and 6 months post implantation.
measure: Oxygen uptake and utilization
timeFrame: 4 weeks prior to implantation and 6 months post implantation.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Snschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: William K Cornwell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sailer C, Edelmann H, Buchanan C, Giro P, Babcock M, Swanson C, Spotts M, Schulte M, Pratt-Cordova A, Coe G, Beindorff M, Page RL 2nd, Ambardekar AV, Pal JD, Kohrt W, Wolfel E, Lawley JS, Tarumi T, Cornwell WK 3rd. Impairments in Blood Pressure Regulation and Cardiac Baroreceptor Sensitivity Among Patients With Heart Failure Supported With Continuous-Flow Left Ventricular Assist Devices. Circ Heart Fail. 2021 Jan;14(1):e007448. doi: 10.1161/CIRCHEARTFAILURE.120.007448. Epub 2021 Jan 19.