Heart FailureHF-eVOLUTIONNCT04292275
Heart Failure Study to Evaluate Vital Signs and Overcome Low Use of Guideline-Directed Therapy by Remote Monitoring
A study testing Biobeat Wrist Watch in people with Heart Failure, run by Amgen at 8 sites in United States.
Trial summary
A study evaluating the impact of remotely collected data, measured using digital technologies, on the use of guideline-recommended heart failure therapy in adult participants with heart failure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Biobeat Wrist Watch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 8 sitesUnited States
- Study dates
- 6 Mar 2020to 1 Oct 2021
- Phase
- Interventional
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of chronic heart failure.
- Ejection fraction equal to or below 40%.
- New York Heart Association (NYHA) class II to class III.
- Enrollment during or within 30 days after a hospitalization, emergency department, or urgent, unscheduled clinic/office visit with primary diagnosis of heart failure.
Who cannot join
- Has received a major organ transplant (e.g., lung, liver, heart, bone marrow, kidney).
- Currently in an investigational device or drug study.
- Unwilling or unable to wear a digital wrist watch device for measuring blood pressure and other parameters during waking hours.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Diagnostic Cardiology Group
Chattanooga, Tennessee, 37404
Duke University Medical Center
Durham, North Carolina, 27710
Inova Heart and Vascular Institute
Falls Church, Virginia, 22042
Yale New Haven Hospital
New Haven, Connecticut, 06520
Cardiology Associates of Fairfield County, PC
Stamford, Connecticut, 06905
Tennessee Center for Clinical Trials, a division of Cardiology and Vascular Associates PLLC
Tullahoma, Tennessee, 37388
Virtua Health Inc.
Voorhees Township, New Jersey, 08043
MercyOne Northeast Iowa Family Medicine and Residency
Waterloo, Iowa, 50702
About this study
Official title: A Randomized, Open-Label, Standard-of-Care-Controlled, Multicenter Study to Evaluate Digital Health Data Use in Managing Guideline-Directed Heart Failure Therapy
A study evaluating the impact of remotely collected data, measured using digital technologies, on the use of guideline-recommended heart failure therapy in adult participants with heart failure.
- Conditions
- Heart Failure
- Being tested
- Biobeat Wrist Watch, Standard of Care
- Keywords
- Digital health, Remote monitoring, Wearable device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biobeat Wrist WatchDevice
Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures. In addition, participants will be provided with a Biobeat wrist watch for continuous measurement and reporting of blood pressure data and with a smartphone to report weight.
Standard of CareOther
Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures.
| Study group | Role | What they receive |
|---|---|---|
| Digital Health Tools + Standard of Care | Experimental | Not described Receives: Device: Biobeat Wrist Watch; Other: Standard of Care |
| Standard of Care | Other | Not described Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Change or Decision That Heart Failure Therapy is Optimal
Area under the curve (AUC) will be calculated for a daily dose-related medication score for beta-blocker, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker/angiotensin neprilysin inhibitor, and aldosterone antagonist therapy.
Measured: Randomization to 6 months
Secondary outcomes (5)
Time to change or decision that heart failure therapy is optimal
Area under the curve (AUC) will be calculated for a daily dose-related medication score for beta-blocker, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker/angiotensin neprilysin inhibitor, and aldosterone antagonist therapy, time to change or decision that dose is optimal.
Measured: Baseline to 6 months
Numerical Health Information Technology Usability Evaluation Scale for Healthcare Provider Scores (Health-ITUES-HCP)
Health-ITUES-HCP will be used to assess the healthcare provider's experience with the digital health tool(s) and data presentation. The scale consists of 36 items. A higher score indicated higher perceived usability of the technology.
Measured: Week 24
Numerical Health Information Technology Usability Evaluation Scale for Participants (Health-ITUES-Subject) Scores
Health-ITUES-Subject will be used to assess the participant's experience with the digital health tool(s). The scale consists of 36 items. A higher score indicated higher perceived usability of the technology.
Measured: Week 24
Change in Numerical Rating of Subject Satisfaction with Heart Failure Therapy
Participants will complete a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied.
Measured: Baseline and Week 24
Change from Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Scores
The KCCQ-23 is a 23-item questionnaire to measure the participant's perception of their health status, which includes heart failure symptoms, impact on physical and social function, and how their heart failure impacts their quality of life. All items are measured on a Likert scale with 5-7 response options. Scores for each item are standardized to range from 0 to 100 with higher scores indicating better health status, fewer symptoms, and greater disease-specific health-related quality of life.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start6 Mar 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Why it stopped: Study closed prematurely due to enrollment challenges exacerbated by COVID-19.
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 AmgenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292275
- Sponsor's protocol ID
- 20180096
- Acronym
- HF-eVOLUTION
- Status last verified
- Aug 2023
- First submitted
- 28 Feb 2020
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Standard-of-Care-Controlled, Multicenter Study to Evaluate Digital Health Data Use in Managing Guideline-Directed Heart Failure Therapy
- ClinicalTrials.gov ID
- NCT04292275
- Acronym / sponsor ID
- HF-eVOLUTION / 20180096
- Conditions
- Heart Failure
- Keywords
- Digital health, Remote monitoring, Wearable device
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study closed prematurely due to enrollment challenges exacerbated by COVID-19.
- Enrolment
- 18 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 3 Mar 2020 (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.
A study evaluating the impact of remotely collected data, measured using digital technologies, on the use of guideline-recommended heart failure therapy in adult participants with heart failure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Health Tools + Standard of Care | Experimental | Device: Biobeat Wrist Watch, Other: Standard of Care |
| Standard of Care | Other | Other: Standard of Care |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- History of chronic heart failure.
- Ejection fraction equal to or below 40%.
- New York Heart Association (NYHA) class II to class III.
- Enrollment during or within 30 days after a hospitalization, emergency department, or urgent, unscheduled clinic/office visit with primary diagnosis of heart failure.
Key exclusion criteria (3 listed)
- Has received a major organ transplant (e.g., lung, liver, heart, bone marrow, kidney).
- Currently in an investigational device or drug study.
- Unwilling or unable to wear a digital wrist watch device for measuring blood pressure and other parameters during waking hours.
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 |
|---|---|---|
| Biobeat Wrist WatchStandard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures. In addition, participants will be provided with a Biobeat wrist watch for continuous measurement and reporting of blood pressure data and with a smartphone to report weight. | Device | Digital Health Tools + Standard of Care |
| Standard of CareStandard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures. | Other | Digital Health Tools + Standard of Care, Standard of Care |
Primary outcome
Time to Change or Decision That Heart Failure Therapy is Optimal
Time frame: Randomization to 6 months
Area under the curve (AUC) will be calculated for a daily dose-related medication score for beta-blocker, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker/angiotensin neprilysin inhibitor, and aldosterone antagonist therapy.
5 secondary outcomes
Time to change or decision that heart failure therapy is optimal
Time frame: Baseline to 6 months
Numerical Health Information Technology Usability Evaluation Scale for Healthcare Provider Scores (Health-ITUES-HCP)
Time frame: Week 24
Numerical Health Information Technology Usability Evaluation Scale for Participants (Health-ITUES-Subject) Scores
Time frame: Week 24
Change in Numerical Rating of Subject Satisfaction with Heart Failure Therapy
Time frame: Baseline and Week 24
Change from Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Scores
Time frame: Baseline and Week 24
Results and safety
The study was stopped early (reason given: Study closed prematurely due to enrollment challenges exacerbated by COVID-19.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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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.
MD study director
Amgen
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biobeat Wrist Watch in people with Heart Failure, run by Amgen at 8 sites 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 4 inclusion and 3 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 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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: Study closed prematurely due to enrollment challenges exacerbated by COVID-19.). 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?
Time to Change or Decision That Heart Failure Therapy is Optimal (time frame: Randomization to 6 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 8 Aug 2023.