Skeletal Muscle Perfusion With LVAD

• Conditions: Heart Failure
• Interventions: Other: Contrast ultrasound skeletal muscle perfusion imaging

• Registration Number: NCT02105831
• Lead Sponsor: Oregon Health and Science University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-02-01
• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-21
• Last Update Posted: 2018-08-23
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• patients deemed to be candidates for a LVAD

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CEU skeletal muscle perfusion imaging	Contrast ultrasound skeletal muscle perfusion imaging	Heart failure with LVAD Contrast ultrasound skeletal muscle perfusion imaging

Primary Outcome Measures

Name	Time	Method
Skeletal muscle perfusion on contrast enhanced ultrasound	3 months	Skeletal muscle perfusion will be quantified: 1. Prior to LVAD placement; 2. 3 months post LVAD placement

Secondary Outcome Measures

Name	Time	Method
6 minute walk test	3 month

Trial Locations

Locations (1)

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States