Clinical trial NCT01233037: Markers of Endothelial Function and Exercise CapaciTy in Patients With Left Ventricular Assist Devices (EFECT LVAD)
Official title: Observational Study Assessing Markers of Endothelial Function and Exercise CapaciTy in Patients With Left Ventricular Assist Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endothelial Cells
Exercise Tolerance
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-11-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the University of Minnesota Cardiology Practice prior to clinically-indicated LVAD implantation.

Brief summary: This is a non-randomized feasibility study of endothelial function, exercise capacity, and outcome following pre-left ventricular assist device (LVAD)therapy and cardiac transplant.

The study period will be 5 years, with 20 patients to be enrolled. The investigators anticipate that 15 patients will survive to complete the one year follow up period.(the published survival rate of LVAD is 75% in one year). 10 patients are anticipated to undergo cardiac transplant within 3 years of initial enrollment and they are followed until their 2nd annual post transplant invasive evaluation.

Markers of endothelial function will be studied to permit comparison with selected clinical outcomes. The hypothesis is that the endothelial functions will be altered after implantation of LVAD then before its implantation, both acutely and chronically, and this may affect the exercise capacity, quality of life and occurrence of cardiac allograft vasculopathy post cardiac transplantation.

Detailed description: This is a non-randomized, feasibility study of endothelial function, exercise capacity, and outcome following pre-LVAD patients through LVAD therapy and cardiac transplantation.

The study period will be 5 years. It is anticipated that 20 patients will be enrolled and 15 will survive (published survival estimate following LVAD is approximately 75% at one year) to complete the one-year follow-up period. 10 patients are anticipated to undergo heart transplant within 3 years of initial enrollment and they will be followed until their 2nd annual post-transplant invasive evaluation.

Eligibility criteria: Inclusion Criteria:

* Advanced heart failure and scheduled LVAD implantation for standard clinical indications.
* Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.

Exclusion Criteria:

* Inability to personally provide informed consent
* Medical activity restriction that precludes ambulation

Primary outcomes:
measure: Determine which markers of vascular function are most highly associated with exercise capacity following LVAD implantation.
timeFrame: 3 years
Secondary outcomes:
measure: Determine which markers are associated with Survival following LVAD
timeFrame: 3 years
measure: To determine which markers are associated with Risk of GI bleeding thought to arise from intestinal AVMs
timeFrame: 3 years
measure: Determine which markers are associated with Risk and severity of coronary allograft vasculopathy at 1 and 2 years post transplant
timeFrame: 5 years
measure: Determine which markers are associated with quality of life
timeFrame: 5 years
measure: Obtain pilot data on the acute endothelial response to exercise in patients with LVAD
timeFrame: 2 years
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Fairview Health Systems Research
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Peter Eckman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tominaga R, Smith W, Massiello A, Harasaki H, Golding LA. Chronic nonpulsatile blood flow. II. Hemodynamic responses to progressive exercise in calves with chronic nonpulsatile biventricular bypass. J Thorac Cardiovasc Surg. 1996 Apr;111(4):857-62. doi: 10.1016/s0022-5223(96)70347-1.