Heart FailureNCT02105831
Skeletal Muscle Perfusion With LVAD
An observational study of Heart Failure, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Contrast ultrasound skeletal muscle perfusion imaging
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2014to Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Heart failure patients being referred for LVAD
Who may be able to join
- patients deemed to be candidates for a LVAD
Who cannot join
- severe peripheral artery disease
- skeletal muscle disorder
- severe congenital heart disease
- pregnancy
- patients <18 yo
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Jonathan R Lindner, MD, 503-494-8750, lindnerj@ohsu.edu
Jonathan R Lindner, MD
About this study
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.
Read the 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
- Being tested
- Contrast ultrasound skeletal muscle perfusion imaging
- Keywords
- left ventricular assist device, contrast ultrasound, perfusion imaging
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast ultrasound skeletal muscle perfusion imagingOther
- Contrast ultrasound perfusion imaging will be performed in patients in whom LVAD will be placed for clinical indications of severe heart failure.
| Study group | Role | What they receive |
|---|---|---|
| CEU skeletal muscle perfusion imaging | Heart failure with LVAD Contrast ultrasound skeletal muscle perfusion imaging Receives: Other: Contrast ultrasound skeletal muscle perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal muscle perfusion on contrast enhanced ultrasound
Skeletal muscle perfusion will be quantified:
- Prior to LVAD placement
- 3 months post LVAD placement
Measured: 3 months
Secondary outcomes (1)
6 minute walk test
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study start1 Feb 2014
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan R. Lindner, MD, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105831
- Sponsor's protocol ID
- CEU in LVAD
- Status last verified
- Aug 2018
- First submitted
- 2 Apr 2014
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Perfusion With LVAD
- ClinicalTrials.gov ID
- NCT02105831
- Acronym / sponsor ID
- CEU in LVAD
- Conditions
- Heart Failure
- Keywords
- left ventricular assist device, contrast ultrasound, perfusion imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CEU skeletal muscle perfusion imaging | – | Other: Contrast ultrasound skeletal muscle perfusion imagingHeart failure with LVAD Contrast ultrasound skeletal muscle perfusion imaging |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Heart failure patients being referred for LVAD
Key inclusion criteria (1 listed)
- patients deemed to be candidates for a LVAD
Key exclusion criteria (5 listed)
- severe peripheral artery disease
- skeletal muscle disorder
- severe congenital heart disease
- pregnancy
- patients <18 yo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast ultrasound skeletal muscle perfusion imaging1. Contrast ultrasound perfusion imaging will be performed in patients in whom LVAD will be placed for clinical indications of severe heart failure. | Other | CEU skeletal muscle perfusion imaging |
Primary outcome
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
1 secondary outcome
6 minute walk test
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan R Lindner, MD (503 494-8750, lindnerj@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skeletal muscle perfusion on contrast enhanced ultrasound (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.