Skeletal Muscle Perfusion With LVAD

August 21, 2018 updated by: Jonathan R. Lindner, MD, Oregon Health and Science University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

1. Heart failure patients being referred for LVAD

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CEU skeletal muscle perfusion imaging
Heart failure with LVAD Contrast ultrasound skeletal muscle perfusion imaging
Other: Contrast ultrasound skeletal muscle perfusion imaging
1. Contrast ultrasound perfusion imaging will be performed in patients in whom LVAD will be placed for clinical indications of severe heart failure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
6 minute walk test
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon Health and Science University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2014

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 4, 2014

First Posted (Estimate)

April 7, 2014

Study Record Updates

Last Update Posted (Actual)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEU in LVAD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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