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NCT Number: NCT01233037

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

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.

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Key information

Conditions

Endothelial Cells Exercise Tolerance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fairview Health Systems Research

Minneapolis, Minnesota, 555455, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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

Treatment and study plan

Primary outcomes

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

    Time frame: 3 years

Secondary outcomes

  1. Determine which markers are associated with Survival following LVAD

    Time frame: 3 years

  2. To determine which markers are associated with Risk of GI bleeding thought to arise from intestinal AVMs

    Time frame: 3 years

  3. Determine which markers are associated with Risk and severity of coronary allograft vasculopathy at 1 and 2 years post transplant

    Time frame: 5 years

  4. Determine which markers are associated with quality of life

    Time frame: 5 years

  5. Obtain pilot data on the acute endothelial response to exercise in patients with LVAD

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Acronym: EFECT-LVAD

Important dates

Study start
2010
Primary completion
2015
Study completion
2016
First posted
Nov 2, 2010
Registry last updated
Aug 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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