Skeletal Muscle Perfusion With LVAD
1 other identifier
observational
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 2, 2014
CompletedFirst Posted
Study publicly available on registry
April 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedAugust 23, 2018
August 1, 2018
5.8 years
April 2, 2014
August 21, 2018
Conditions
Keywords
Outcome Measures
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
3 months
Secondary Outcomes (1)
6 minute walk test
3 month
Study Arms (1)
CEU skeletal muscle perfusion imaging
Heart failure with LVAD Contrast ultrasound skeletal muscle perfusion imaging
Interventions
1\. Contrast ultrasound perfusion imaging will be performed in patients in whom LVAD will be placed for clinical indications of severe heart failure.
Eligibility Criteria
1\. Heart failure patients being referred for LVAD
You may qualify if:
- patients deemed to be candidates for a LVAD
You may not qualify if:
- severe peripheral artery disease
- skeletal muscle disorder
- severe congenital heart disease
- pregnancy
- patients \<18 yo
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Health & Science University
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
April 2, 2014
First Posted
April 7, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
August 23, 2018
Record last verified: 2018-08