Heart FailureNCT05127785
Frailty in Individuals With Advanced Heart Failure Part 2
An observational study of Heart Failure and Frailty, run by University of Southern California at 1 site in United States.
Trial summary
To investigate how measures of frailty, assessed during occupational therapy (OT) evaluation and intervention impact decision for advanced heart failure (HF) therapies and postoperative outcomes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure, Frailty
- What is being tested?
- LVAD or Heart Transplant
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2021to 31 Dec 2023
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Individuals with heart failure undergoing evaluation for advanced heart failure therapy.
Who may be able to join
- Individuals will be included in this study if they were evaluated for advanced heart failure therapies at Keck Hospital from 1/1/2019-6/30/2021. This will be determined through data from the electronic medical record.
Who cannot join
- Patients who did not receive an occupational therapy evaluation prior to advanced heart failure intervention decision.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate how measures of frailty, assessed during occupational therapy (OT) evaluation and intervention impact decision for advanced heart failure (HF) therapies and postoperative outcomes.
- Conditions
- Heart Failure, Frailty
- Being tested
- LVAD or Heart Transplant
- Medical subject headings
- Heart Failure, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVAD or Heart TransplantProcedure or surgery
Patients undergoing advanced heart failure intervention including LVAD implantation or heart transplantation
| Study group | Role | What they receive |
|---|---|---|
| Medical Management | Patients deemed not candidates for advanced heart failure interventions. | |
| Left Ventricular Assist Device (LVAD) | Recipients of a left ventricular assist device Receives: Procedure: LVAD or Heart Transplant | |
| Heart Transplant | Recipients of a heart transplant. Receives: Procedure: LVAD or Heart Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Length of Stay
Length of hospital stay after intervention
Measured: 1 to 500 days
Rate of Readmission
Rate of Readmission after initial hospital discharge
Measured: 30 to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start9 Nov 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2023
Why it stopped: Transitioned professional responsibilities.
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 University of Southern CaliforniaThe 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elyse Peterson, University of Southern California
- Investigators
- Elyse Peterson, OTD, OTR/L, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127785
- Sponsor's protocol ID
- UP-21-00687
- Status last verified
- May 2024
- First submitted
- 9 Nov 2021
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty in Individuals With Advanced Heart Failure Part 2
- ClinicalTrials.gov ID
- NCT05127785
- Acronym / sponsor ID
- UP-21-00687
- Conditions
- Heart Failure, Frailty
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Transitioned professional responsibilities.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- 9 Nov 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Nov 2021 (actual)
- 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.
To investigate how measures of frailty, assessed during occupational therapy (OT) evaluation and intervention impact decision for advanced heart failure (HF) therapies and postoperative outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medical Management | – | –Patients deemed not candidates for advanced heart failure interventions. |
| Left Ventricular Assist Device (LVAD) | – | Procedure: LVAD or Heart TransplantRecipients of a left ventricular assist device |
| Heart Transplant | – | Procedure: LVAD or Heart TransplantRecipients of a heart transplant. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Individuals with heart failure undergoing evaluation for advanced heart failure therapy.
Key inclusion criteria (1 listed)
- Individuals will be included in this study if they were evaluated for advanced heart failure therapies at Keck Hospital from 1/1/2019-6/30/2021. This will be determined through data from the electronic medical record.
Key exclusion criteria (1 listed)
- Patients who did not receive an occupational therapy evaluation prior to advanced heart failure intervention decision.
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 |
|---|---|---|
| LVAD or Heart TransplantPatients undergoing advanced heart failure intervention including LVAD implantation or heart transplantation | Procedure or surgery | Heart Transplant, Left Ventricular Assist Device (LVAD) |
Primary outcome
Hospital Length of Stay
Time frame: 1 to 500 days
Length of hospital stay after intervention
Rate of Readmission
Time frame: 30 to 90 days
Rate of Readmission after initial hospital discharge
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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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.
Elyse Peterson, OTD, OTR/L principal investigator
University of Southern California
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 and Frailty, run by University of Southern California 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 1 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: withdrawn, as of the sponsor's last update on 30 May 2024. 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 was withdrawn before enrolling participants, so there are no results.
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?
Hospital Length of Stay (time frame: 1 to 500 days). The study lists 2 primary outcomes in all. 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 30 May 2024.