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Skeletal Muscle Perfusion With LVAD

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02105831
Enrollment
30
Registered
2014-04-07
Start date
2014-02-01
Completion date
2019-12-31
Last updated
2018-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

left ventricular assist device, contrast ultrasound, perfusion imaging

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.

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.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Skeletal muscle perfusion on contrast enhanced ultrasound3 monthsSkeletal muscle perfusion will be quantified: 1. Prior to LVAD placement 2. 3 months post LVAD placement

Secondary

MeasureTime frame
6 minute walk test3 month

Countries

United States

Contacts

Primary ContactJonathan R Lindner, MD
lindnerj@ohsu.edu503 494-8750

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026