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

Exercise Tolerance Clinical Trial

— EFECT-LVAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233037
• Other study ID #: 1007M86679
• Status: Completed
• Phase: N/A
• First received: November 1, 2010
• Last updated: August 3, 2016
• Start date: October 2010
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endothelial Cells
• Exercise Tolerance

Locations

Country	Name	City	State
United States	Fairview Health Systems Research	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine which markers of vascular function are most highly associated with exercise capacity following LVAD implantation.		3 years	No
Secondary	Determine which markers are associated with Survival following LVAD		3 years	No
Secondary	To determine which markers are associated with Risk of GI bleeding thought to arise from intestinal AVMs		3 years	No
Secondary	Determine which markers are associated with Risk and severity of coronary allograft vasculopathy at 1 and 2 years post transplant		5 years	No
Secondary	Determine which markers are associated with quality of life		5 years	No
Secondary	Obtain pilot data on the acute endothelial response to exercise in patients with LVAD		2 years	No

External Links

•   the study location
•   the study sponsor website