Markers of Endothelial Function and Exercise CapaciTy in Patients With Left Ventricular Assist Devices (EFECT LVAD) (EFECT-LVAD)

University of Minnesota (UMN)

Status: Completed

Conditions: Exercise Tolerance; Endothelial Cells

Study type: Observational

Funder types: Other

Identifiers

NCT01233037

1007M86679

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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