CClinicalTrials.gg
Status unknownNCT02105831Updated Aug 23, 2018

Skeletal Muscle Perfusion With LVAD

An observational study in Heart Failure, sponsored by Oregon Health and Science University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-08-23.

Sponsored by Oregon Health and Science University · Observational

The sponsor has not verified this record recently (last verified Aug 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
30
Ages
18 Years to 70 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Heart Failure

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Keywords

  • left ventricular assist device
  • contrast ultrasound
  • perfusion imaging
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's planned enrollment of 30 is below the median of 200 across 1,678 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Oregon Health and Science University is the lead sponsor of 676 studies on the registry; 136 are open to participants now.

Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

  1. Heart failure patients being referred for LVAD

Inclusion criteria

  • patients deemed to be candidates for a LVAD

Exclusion criteria

Exclusion Criteria:

  • severe peripheral artery disease
  • skeletal muscle disorder
  • severe congenital heart disease
  • pregnancy
  • patients \<18 yo
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Groups and cohorts

  • CEU skeletal muscle perfusion imaging

    Heart failure with LVAD Contrast ultrasound skeletal muscle perfusion imaging

    Other: Contrast ultrasound skeletal muscle perfusion imaging

Interventions

  • OtherContrast 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.

06

What researchers measure

Primary outcomes

  1. Skeletal muscle perfusion on contrast enhanced ultrasound

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

    Time frame: 3 months

Secondary outcomes

  1. 6 minute walk test

    Time frame: 3 month

07

Study locations

1 of 1 sites recruiting
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
    • Jonathan R Lindner, MD · Contact · lindnerj@ohsu.edu · 503-494-8750
    • Jonathan R Lindner, MD · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02105831
Lead sponsor
Oregon Health and Science University
Responsible party
Jonathan R. Lindner, MD (Professor of Medicine, Oregon Health and Science University) — Principal investigator
First posted
Apr 7, 2014
Start date
Feb 1, 2014
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Aug 23, 2018

Study contacts

Jonathan R Lindner, MD
Contact
lindnerj@ohsu.edu
503 494-8750

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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