Skeletal Muscle Perfusion With LVAD

NCT ID: NCT02105831

Last Updated: 2018-08-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-01
• Study Completion Date: 2019-12-31

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

CEU skeletal muscle perfusion imaging

Heart failure with LVAD Contrast ultrasound skeletal muscle perfusion imaging

Contrast ultrasound skeletal muscle perfusion imaging

Intervention Type: OTHER

1\. Contrast ultrasound perfusion imaging will be performed in patients in whom LVAD will be placed for clinical indications of severe heart failure.

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: lead

Responsible Party

Jonathan R. Lindner, MD

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Oregon Health & Science University

Portland, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jonathan R Lindner, MD

Role: CONTACT

lindnerj@ohsu.edu

503 494-8750

Facility Contacts

Jonathan R Lindner, MD

Role: primary

lindnerj@ohsu.edu

503-494-8750

Other Identifiers

CEU in LVAD

Identifier Type: -

Identifier Source: org_study_id