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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01233037
First received: November 1, 2010
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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.


Condition
Endothelial Cells
Exercise Tolerance

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observational Study Assessing Markers of Endothelial Function and Exercise CapaciTy in Patients With Left Ventricular Assist Devices

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Determine which markers of vascular function are most highly associated with exercise capacity following LVAD implantation. [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine which markers are associated with Survival following LVAD [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To determine which markers are associated with Risk of GI bleeding thought to arise from intestinal AVMs [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Determine which markers are associated with Risk and severity of coronary allograft vasculopathy at 1 and 2 years post transplant [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Determine which markers are associated with quality of life [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Obtain pilot data on the acute endothelial response to exercise in patients with LVAD [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.)


Estimated Enrollment: 20
Study Start Date: October 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01233037

Locations
United States, Minnesota
Fairview Health Systems Research
Minneapolis, Minnesota, United States, 555455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Peter Eckman, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Additional Information:
Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01233037     History of Changes
Other Study ID Numbers: 1007M86679
Study First Received: November 1, 2010
Last Updated: March 20, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 23, 2014