- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02105831
Skeletal Muscle Perfusion With LVAD
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:
- To evaluate skeletal muscle and heart perfusion studies before and after LVAD implantation
- To compare functional status with degree of skeletal muscle perfusion.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jonathan R Lindner, MD
- Phone Number: 503 494-8750
- Email: lindnerj@ohsu.edu
Study Locations
-
-
Oregon
-
Portland, Oregon, United States, 97239
- Recruiting
- Oregon Health & Science University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CEU skeletal muscle perfusion imaging
Heart failure with LVAD 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skeletal muscle perfusion on contrast enhanced ultrasound
Time Frame: 3 months
|
Skeletal muscle perfusion will be quantified:
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
6 minute walk test
Time Frame: 3 month
|
3 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEU in LVAD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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