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

NCT01233037 | Completed

• 1 other identifier: 1007M86679
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Endothelial Cells; Exercise Tolerance

Outcome Measures

Primary Outcomes (1)

• Determine which markers of vascular function are most highly associated with exercise capacity following LVAD implantation.

  3 years

Secondary Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Fairview Health Systems Research

Minneapolis, Minnesota, 555455, United States

Location

Related Publications (1)

• 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.

  PMID: 8614147 BACKGROUND

Related Links

• the study sponsor website
• the study location

Biospecimen

Retention: SAMPLES WITH DNA

Some of the blood collected at each visit will stored by the investigator for up to 5 years. Samples will be kept in our laboratory for up to 5 years as plasma, after which they will be destroyed. Samples will be identified only by a code number, only the principal investigator and his research staff will have access to the code. The results of the future tests will not be communicated to subjects in this study. The samples are stored in the form of plasma from Peripheral blood for additional markers of endothelial function (Soluble thrombomodulin, IL-6, etc.)

Study Officials

• Peter Eckman, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 2, 2010
• Study Start: October 1, 2010
• Primary Completion: November 1, 2015
• Study Completion: June 1, 2016
• Last Updated: August 5, 2016

Record last verified: 2016-08

Locations

US (1)