Recruiting

Skeletal Muscle Perfusion

Sponsor:

Oregon Health and Science University

Code:

NCT02105831

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Contrast ultrasound skeletal muscle perfusion imaging

Study Details

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.

Conditions

Heart Failure

Study ID

NCT02105831

Start date

Feb 1, 2014

Status verified date

Aug, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Arms

CEU skeletal muscle perfusion imaging

Heart failure with LVAD Contrast ultrasound skeletal muscle perfusion imaging

Interventions

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.

Primary outcome measure

  • Skeletal muscle perfusion on contrast enhanced ultrasound [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Jonathan R Lindner, MD

503 494-8750lindnerj@ohsu.edu

Locations

Oregon Health & Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Jonathan R Lindner, MD

503-494-8750lindnerj@ohsu.edu

Principal Investigator:

Jonathan R Lindner, MD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Aug 23, 2018

Last verified

Aug, 2018

Keywords

  • left ventricular assist device
  • contrast ultrasound
  • perfusion imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2018-08-23.