Systolic Heart FailureNCT02156583
Frailty: Prevalence and Response to Left Ventricular Assist Device Therapy in Older Heart Failure Patients
An observational study of Systolic Heart Failure, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This is an observational study evaluating changes in frailty and associated impairments in older heart failure patients receiving left ventricular assist device therapy. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Systolic Heart Failure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jul 2017
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive heart failure patients 60 years old or older undergoing left ventricular assist device implantation.
Who may be able to join
- 60 years old or older
- Scheduled to undergo left ventricular assist device implantation at Thomas Jefferson University
Who cannot join
- Unable or unwilling to provide informed consent
- Unable to complete baseline frailty assessment
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
This is an observational study evaluating changes in frailty and associated impairments in older heart failure patients receiving left ventricular assist device therapy.
- Conditions
- Systolic Heart Failure
- Keywords
- Ventricular Assist Device, Skeletal Muscle, Frailty, Older adults
- Medical subject headings
- Heart Failure, Systolic, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Older, left ventricular assist device | Older heart failure patients undergoing left ventricular assist device implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in frailty following left ventricular assist device implantation
Frailty will be assess based on the domains initially described by Fried and colleagues: weakness, low physical activity, unintentional weight loss, slowness and exhaustion. Additional frailty measures include the Short Physical Performance Battery (SPPB), as well as gait speed and hand grip strength as single item measures.
Measured: Baseline (prior to surgery); 10 days, 1 month, 3 months, and 6 months post-operatively
Secondary outcomes (1)
Skeletal muscle size as measured by ultrasonography
Measured: Baseline (prior to surgery); 10 days and 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systolic Heart FailureStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Collaborators
- Thoratec Corporation, National Skeletal Muscle Research Center, Greater New York Geriatric Cardiology Consortium
- Responsible party
- Sponsor
- Investigators
- Gordon R Reeves, MD, MPT, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156583
- Sponsor's protocol ID
- 14C.146
- Status last verified
- Apr 2018
- First submitted
- 3 Jun 2014
- Last updated
- 10 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Maurer MS, Horn E, Reyentovich A, Dickson VV, Pinney S, Goldwater D, Goldstein NE, Jimenez O, Teruya S, Goldsmith J, Helmke S, Yuzefpolskaya M, Reeves GR. Can a Left Ventricular Assist Device in Individuals with Advanced Systolic Heart Failure Improve or Reverse Frailty? J Am Geriatr Soc. 2017 Nov;65(11):2383-2390. doi: 10.1111/jgs.15124. Epub 2017 Sep 21.
PubMed 28940248
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty: Prevalence and Response to Left Ventricular Assist Device Therapy in Older Heart Failure Patients
- ClinicalTrials.gov ID
- NCT02156583
- Acronym / sponsor ID
- 14C.146
- Conditions
- Systolic Heart Failure
- Keywords
- Ventricular Assist Device, Skeletal Muscle, Frailty, Older adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- Thoratec Corporation, National Skeletal Muscle Research Center, Greater New York Geriatric Cardiology Consortium
- Study start
- May 2014 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 5 Jun 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.
This is an observational study evaluating changes in frailty and associated impairments in older heart failure patients receiving left ventricular assist device therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Older, left ventricular assist device | – | –Older heart failure patients undergoing left ventricular assist device implantation |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive heart failure patients 60 years old or older undergoing left ventricular assist device implantation.
Key inclusion criteria (2 listed)
- 60 years old or older
- Scheduled to undergo left ventricular assist device implantation at Thomas Jefferson University
Key exclusion criteria (2 listed)
- Unable or unwilling to provide informed consent
- Unable to complete baseline frailty assessment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in frailty following left ventricular assist device implantation
Time frame: Baseline (prior to surgery); 10 days, 1 month, 3 months, and 6 months post-operatively
Frailty will be assess based on the domains initially described by Fried and colleagues: weakness, low physical activity, unintentional weight loss, slowness and exhaustion. Additional frailty measures include the Short Physical Performance Battery (SPPB), as well as gait speed and hand grip strength as single item measures.
1 secondary outcome
Skeletal muscle size as measured by ultrasonography
Time frame: Baseline (prior to surgery); 10 days and 3 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2018.
- Results publication: PubMed 28940248Maurer MS, Horn E, Reyentovich A, Dickson VV, Pinney S, Goldwater D, Goldstein NE, Jimenez O, Teruya S, Goldsmith J, Helmke S, Yuzefpolskaya M, Reeves GR. Can a Left Ventricular Assist Device in Individuals with Advanced Systolic Heart Failure Improve or Reverse Frailty? J Am Geriatr Soc. 2017 Nov;65(11):2383-2390. doi: 10.1111/jgs.15124. Epub 2017 Sep 21.
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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.
Gordon R Reeves, MD, MPT principal investigator
Thomas Jefferson University
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 Systolic Heart Failure, run by Thomas Jefferson 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 10 Apr 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in frailty following left ventricular assist device implantation (time frame: Baseline (prior to surgery); 10 days, 1 month, 3 months, and 6 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02156583, which also lists 1 linked publication.
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 10 Apr 2018.