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

Observational Study Assessing Markers of Endothelial Function and Exercise CapaciTy in Patients With Left Ventricular Assist Devices

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.

Study Overview

• Status: Completed
• Conditions: Exercise Tolerance; Endothelial Cells

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 Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 555455
      • Fairview Health Systems Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the University of Minnesota Cardiology Practice prior to clinically-indicated LVAD implantation.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Determine which markers are associated with Risk and severity of coronary allograft vasculopathy at 1 and 2 years post transplant	5 years
Determine which markers are associated with quality of life	5 years
Obtain pilot data on the acute endothelial response to exercise in patients with LVAD	2 years

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Peter Eckman, MD, University of Minnesota

Publications and helpful links

General Publications

• 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.

Helpful Links

• the study sponsor website
• the study location

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: November 1, 2010
• First Submitted That Met QC Criteria: November 1, 2010
• First Posted (Estimate): November 2, 2010

Study Record Updates

• Last Update Posted (Estimate): August 5, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 1007M86679