Heart Failure With Reduced Ejection FractionHome PredictNCT03479424
Home Outpatient Monitoring and Engagement to Predict HF Exacerbation
An observational study of Heart Failure With Reduced Ejection Fraction, run by University of California, San Francisco at 1 site in United States.
Trial summary
The HOME PREDICT HF study looks at new ways to predict hospitalizations for heart failure. We will use a set of devices at home and surveys to collect information about patient's health. This study uses the Eureka app, a new study app developed by the University of California, San Francisco. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Observational
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2018to 1 Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults presenting with a diagnosis of reduced ejection fraction (LVEF <= 40%), NYHA class II-IV) who have had a hospitalization for HF in the previous 6 months.
Who may be able to join
- Outpatient and cared for by a PINNACLE Registry practice
- Age ≥ 18 years old
- Has a diagnosis of HF in the PINNACLE Registry/Medical Record
- Seen by PINNACLE practice within the last 12 months
- Has an LVEF ≤40% on their last data entry (within 1 year) in the PINNACLE Registry
- NYHA Class II-IV by self-report
Show all 10Show fewer
- Has had a hospitalization for HF in the previous 6 months by self-report
- Owns an Android or iOS smartphone, within Verizon cellular coverage zone in order to allow for data submission.
- Sleep in the same bed at least 5 days per week
- Willingness to complete the required surveys, measurements and study activities.
Who cannot join
- Home oxygen use
- Current or planned ventricular assist device
- Previously or currently on a heart transplant list
- Chronic dialysis
- A diagnosis of any cancer and undergoing active treatment
- In hospice or palliative care
Show all 11Show fewer
- Planned surgery/procedure in the next 3 months
- Planned extended time away from home (>2 weeks) in the next 3 months
- Living in a skilled nursing facility or other chronic care facility
- Pregnancy or planned pregnancy in the next 3 months
- Inability or unwillingness to consent and/or follow requirements of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94105
About this study
Official title: Home Outpatient Monitoring and Engagement to Predict HF Exacerbation (HOME PREDICT-HF)
The HOME PREDICT HF study looks at new ways to predict hospitalizations for heart failure. We will use a set of devices at home and surveys to collect information about patient's health. This study uses the Eureka app, a new study app developed by the University of California, San Francisco. The study is designed to happen remotely, using this application on a patient's smartphone, so that is as convenient as possible to participate.
Read the detailed description
HOME PREDICT HF is single center, prospective, unblinded, randomly assigned training and validation observational cohorts to develop machine learning algorithms from an in-home suite of sensors in order to predict 3-month heart failure hospitalization and/or emergency department visits. Study population includes adults presenting with a diagnosis of reduced ejection fraction (LVEF <= 40%), NYHA class II-IV) who have had a hospitalization for HF in the previous 6 months. The study objectives include (1) To collect observational data from multiple sensors, patient-reported outcomes, and medical record data to develop (train) machine-learning algorithms (2) To validate trained algorithms in a separate validation cohort (3) To collect data to inform the design of a future intervention study. The primary outcome is Ninety-day heart failure hospitalization/emergency department visit for heart failure.
- Being tested
- Observational
- Keywords
- hospitalization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Also called The MYIA in-home suite of devices.
The MYIA in-home suite of devices.
| Study group | Role | What they receive |
|---|---|---|
| Training Set | n = 333 Receives: Other: Observational | |
| Validation Set | n = 167 Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Failure Hospitalization/ ED Visit
Ninety-day heart failure hospitalization/emergency department visit for heart failure.
Measured: 90 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start8 Oct 2018
- Primary completion1 Mar 2019
- Study completion1 Mar 2019
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- MYIA Labs, Inc.
- Responsible party
- Sponsor
- Investigators
- Jeff Olgin, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03479424
- Sponsor's protocol ID
- 18-24445
- Acronym
- Home Predict
- Status last verified
- Dec 2019
- First submitted
- 20 Mar 2018
- Last updated
- 20 Dec 2019
- 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 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Outpatient Monitoring and Engagement to Predict HF Exacerbation (HOME PREDICT-HF)
- ClinicalTrials.gov ID
- NCT03479424
- Acronym / sponsor ID
- Home Predict / 18-24445
- Keywords
- hospitalization
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- MYIA Labs, Inc.
- Study start
- 8 Oct 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 27 Mar 2018 (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.
The HOME PREDICT HF study looks at new ways to predict hospitalizations for heart failure. We will use a set of devices at home and surveys to collect information about patient's health. This study uses the Eureka app, a new study app developed by the University of California, San Francisco. The study is designed to happen remotely, using this application on a patient's smartphone, so that is as convenient as possible to participate.
Detailed description
HOME PREDICT HF is single center, prospective, unblinded, randomly assigned training and validation observational cohorts to develop machine learning algorithms from an in-home suite of sensors in order to predict 3-month heart failure hospitalization and/or emergency department visits. Study population includes adults presenting with a diagnosis of reduced ejection fraction (LVEF <= 40%), NYHA class II-IV) who have had a hospitalization for HF in the previous 6 months. The study objectives include (1) To collect observational data from multiple sensors, patient-reported outcomes, and medical record data to develop (train) machine-learning algorithms (2) To validate trained algorithms in a separate validation cohort (3) To collect data to inform the design of a future intervention study. The primary outcome is Ninety-day heart failure hospitalization/emergency department visit for heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training Set | – | Other: Observationaln = 333 |
| Validation Set | – | Other: Observationaln = 167 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults presenting with a diagnosis of reduced ejection fraction (LVEF <= 40%), NYHA class II-IV) who have had a hospitalization for HF in the previous 6 months.
Key inclusion criteria (10 listed)
- Outpatient and cared for by a PINNACLE Registry practice
- Age ≥ 18 years old
- Has a diagnosis of HF in the PINNACLE Registry/Medical Record
- Seen by PINNACLE practice within the last 12 months
- Has an LVEF ≤40% on their last data entry (within 1 year) in the PINNACLE Registry
Key exclusion criteria (11 listed)
- Home oxygen use
- Current or planned ventricular assist device
- Previously or currently on a heart transplant list
- Chronic dialysis
- A diagnosis of any cancer and undergoing active treatment
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 |
|---|---|---|
| ObservationalAlso: The MYIA in-home suite of devices.The MYIA in-home suite of devices. | Other | Training Set, Validation Set |
Primary outcome
Heart Failure Hospitalization/ ED Visit
Time frame: 90 day
Ninety-day heart failure hospitalization/emergency department visit for heart failure.
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
- 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.
Jeff Olgin, MD principal investigator
University of California, San Francisco
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 With Reduced Ejection Fraction, run by University of California, San Francisco 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 10 inclusion and 11 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: stopped early, as of the sponsor's last update on 20 Dec 2019. 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 stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
Heart Failure Hospitalization/ ED Visit (time frame: 90 day). 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 20 Dec 2019.