Expired Study
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Minneapolis, Minnesota


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.


Study summary:

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.


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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.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


Study is Available At:


Original ID:

1007M86679


NCT ID:

NCT01233037


Secondary ID:


Study Acronym:

EFECT-LVAD


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Minnesota - Clinical and Translational Science Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case Control, Time Perspectiv


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

20


Enrollment Type:

Actual


Overall Contact Information

Official Name:Peter Eckman, MD
Principal Investigator
University of Minnesota - Clinical and Translational Science Institute

Study Dates

Start Date:October 2010
Completion Date:June 2016
Completion Type:Actual
Primary Completion Date:November 2015
Primary Completion Type:Actual
Verification Date:August 2016
Last Changed Date:August 3, 2016
First Received Date:November 1, 2010

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Obtain pilot data on the acute endothelial response to exercise in patients with LVAD
Time Frame:2 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Determine which markers are associated with quality of life
Time Frame:5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Determine which markers are associated with Risk and severity of coronary allograft vasculopathy at 1 and 2 years post transplant
Time Frame:5 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:To determine which markers are associated with Risk of GI bleeding thought to arise from intestinal AVMs
Time Frame:3 years
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Determine which markers are associated with Survival following LVAD
Time Frame:3 years
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Determine which markers of vascular function are most highly associated with exercise capacity following LVAD implantation.
Time Frame:3 years
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Minnesota - Clinical and Translational Science Institute

Samples and Retentions

Sample Retention:Samples With DNA
Description: 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 Population: Subjects will be recruited from the University of Minnesota Cardiology Practice prior to clinically-indicated LVAD implantation.
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation: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.
PMID:8614147

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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