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Clinical Trials/NCT02105831
NCT02105831
Unknown
N/A

Skeletal Muscle Perfusion With LVAD

Oregon Health and Science University1 site in 1 country30 target enrollmentFebruary 1, 2014
ConditionsHeart Failure

Overview

Phase
N/A
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Oregon Health and Science University
Enrollment
30
Locations
1
Primary Endpoint
Skeletal muscle perfusion on contrast enhanced ultrasound
Last Updated
7 years ago

Overview

Brief Summary

Advanced heart failure (when the heart pump fails) is associated with symptoms such as shortness of breath and extreme fatigue. Some of these symptoms are simply due to failure of the pump, however abnormal regulation of blood flow to the muscles of the body is also a potential mechanism. Left ventricular assist devices are mechanical pumps used to compensate for patients with failing hearts either as a bridge to heart transplant or as long term therapy. Whether or not these pumps improve muscle flow and whether this is a determinant in the improvement of symptoms is unknown. Understanding how skeletal muscle and heart perfusion is altered in heart failure patients before and after implantation of an LVAD could provide further insight into the beneficial effects of this therapy.

Specific Aims:

  1. To evaluate skeletal muscle and heart perfusion studies before and after LVAD implantation
  2. To compare functional status with degree of skeletal muscle perfusion.

Detailed Description

Methods: Thirty patients deemed to be candidates for LVAD from either outpatient heart failure clinic or inpatient cardiology service will be studies. Skeletal muscle perfusion imaging using standard of care ultrasound technology will be performed prior to LVAD implant and then 3 months post implant. Functional status by six minute walk test and specialized stress test will be assessed at 3 months post implant.

Registry
clinicaltrials.gov
Start Date
February 1, 2014
End Date
December 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jonathan R. Lindner, MD

Professor of Medicine

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

  • patients deemed to be candidates for a LVAD

Exclusion Criteria

  • severe peripheral artery disease
  • skeletal muscle disorder
  • severe congenital heart disease
  • pregnancy
  • patients \<18 yo

Outcomes

Primary Outcomes

Skeletal muscle perfusion on contrast enhanced ultrasound

Time Frame: 3 months

Skeletal muscle perfusion will be quantified: 1. Prior to LVAD placement 2. 3 months post LVAD placement

Secondary Outcomes

  • 6 minute walk test(3 month)

Study Sites (1)

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