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Skeletal Muscle Perfusion With LVAD

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ClinicalTrials.gov Identifier: NCT02105831
Recruitment Status : Recruiting
First Posted : April 7, 2014
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Jonathan R. Lindner, MD, 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.

Condition or disease Intervention/treatment
Heart Failure Other: Contrast ultrasound skeletal muscle perfusion imaging

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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Actual Study Start Date : February 1, 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CEU skeletal muscle perfusion imaging
Heart failure with LVAD Contrast ultrasound skeletal muscle perfusion imaging
Other: 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.




Primary Outcome Measures :
  1. Skeletal muscle perfusion on contrast enhanced ultrasound [ Time Frame: 3 months ]

    Skeletal muscle perfusion will be quantified:

    1. Prior to LVAD placement
    2. 3 months post LVAD placement


Secondary Outcome Measures :
  1. 6 minute walk test [ Time Frame: 3 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
1. Heart failure patients being referred for LVAD
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02105831


Contacts
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Contact: Jonathan R Lindner, MD 503 494-8750 lindnerj@ohsu.edu

Locations
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United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Jonathan R Lindner, MD    503-494-8750    lindnerj@ohsu.edu   
Principal Investigator: Jonathan R Lindner, MD         
Sponsors and Collaborators
Oregon Health and Science University

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Responsible Party: Jonathan R. Lindner, MD, Professor of Medicine, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT02105831     History of Changes
Other Study ID Numbers: CEU in LVAD
First Posted: April 7, 2014    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018
Keywords provided by Jonathan R. Lindner, MD, Oregon Health and Science University:
left ventricular assist device
contrast ultrasound
perfusion imaging
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases