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

Completed

• Conditions: Exercise Tolerance; Endothelial Cells

• Registration Number: NCT01233037
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-02
• Primary Completion: 2015-11
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-03
• Last Update Posted: 2016-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine which markers of vascular function are most highly associated with exercise capacity following LVAD implantation.	3 years

Secondary Outcome Measures

Name	Time	Method
Determine which markers are associated with quality of life	5 years
Determine which markers are associated with Survival following LVAD	3 years
To determine which markers are associated with Risk of GI bleeding thought to arise from intestinal AVMs	3 years
Obtain pilot data on the acute endothelial response to exercise in patients with LVAD	2 years
Determine which markers are associated with Risk and severity of coronary allograft vasculopathy at 1 and 2 years post transplant	5 years

Trial Locations

Locations (1)

Fairview Health Systems Research; 🇺🇸 Minneapolis, Minnesota, United States