Heart Failure With Reduced Ejection FractionNCT05602454
Virtual Care to Improve Heart Failure Outcomes (VITAL-HF)
A study testing Digital Heart Failure Medication Titration in people with Heart Failure With Reduced Ejection Fraction, run by Duke University at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate how safe and effective a remote, digital intervention is that helps clinicians use and optimally adjust heart failure medications, compared to usual care medication use and adjustment, in participants with heart failure with reduced ejection fraction 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?
- Digital Heart Failure Medication Titration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 7 sitesUnited States
- Study dates
- 2 Dec 2022to 5 Mar 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years of age
- Diagnosis of HF and LVEF <40% on most recent imaging assessment within 1 year prior to screening. Any validated method for assessing LVEF may be used for enrollment including echocardiogram, cardiac magnetic resonance imaging, etc. For participants with an LVEF reported qualitatively (e.g., moderate LV dysfunction) or as a range on the most recent imaging assessment that includes 40% (e.g., 35-45%), then the site investigator should review the imaging study and determine if the participant has an LVEF <40%. Participants with a new diagnosis of HFrEF may be enrolled. The enrollment will be monitored to ensure no more than 50% of the total cohort have new-onset HFrEF.
- Access to a smartphone including through a family member of caregiver
- Fluent in written and spoken English
Who cannot join
- Optimized or nearly-optimized on evidence-based medical therapies for HFrEF as determined by local investigator.
- Current pregnancy
- Chronic use of intravenous inotropic medications including milrinone, dobutamine, or dopamine
- eGFR of <20 mL/min/1.73m2 or ongoing chronic dialysis at screening
- Prior heart transplant
- Current or planned left ventricular assist device
Show all 9Show fewer
- Currently receiving hospice care
- Chronically resides in an assisted living or skilled nursing facility where food and medications are managed by facility personnel
- Terminal illness other than HF with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27710
Ascension St. Vincent
Indianapolis, Indiana, 46260
The University of Kansas Medical Center
Kansas City, Kansas, 66160
Saint Luke's Health Systems
Kansas City, Missouri, 64111
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32405
About this study
Official title: Virtual Care to Improve Heart Failure Outcomes (VITAL-HF) Randomized Controlled Trial
The purpose of this study is to evaluate how safe and effective a remote, digital intervention is that helps clinicians use and optimally adjust heart failure medications, compared to usual care medication use and adjustment, in participants with heart failure with reduced ejection fraction
- Being tested
- Digital Heart Failure Medication Titration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Heart Failure Medication TitrationOther
Story Health Platform, which is a remote, digital tool that provides treating clinicians collected data to make clinical decisions regarding heart failure medication titration.
| Study group | Role | What they receive |
|---|---|---|
| Digital Heart Failure Medication Titration | Experimental | The Story Health platform will remotely receive daily vital signs directly from a blood pressure cuff and scale provided to the participant. Participants will also report any symptoms. All of this data will be transmitted, via the platform, to the treating clinician at the site, who will create care plans for medication titration and make clinical decisions. The care plans will be implemented with assistance from health coaches from Story Health Inc. Receives: Other: Digital Heart Failure Medication Titration |
| Usual Care | No intervention | Routine clinical care will be followed. Participants will also receive a blood pressure cuff and scale, though the data will not be routinely fed back to the treating clinicians unless requested. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in medical therapy, as measured by the Heart Failure Medical Therapy Score
Scores are 0-3 for 7 key medication classes for heart failure with reduced ejection fraction where 0 represents no use of the medication class
Measured: Baseline, 6 months
Secondary outcomes (5)
Change in medical therapy, as measured by the Kansas City Medical Optimization score
Scores are the average of the total daily dose to target dose values for HF medications. Scores range from 0-100.
Measured: Baseline, 6 months
Intensification of evidence-based medical therapies, measured by number of participants with reported changes.
Proportion of participants with any intensification of and cumulative number of intensifications of evidence-based medical therapies for HFrEF from baseline to last follow-up.
Measured: baseline, 6 months
Proportion of participants on 50% of published target doses of evidence-based medical therapies for HFrEF at last follow-up.
The last measure dose will be compared with the target dose in the 2022 Heart Failure Guidelines.
Measured: 6 months
Proportion of participants on 100% of published target doses of evidence-based medical therapies for HFrEF at last follow-up.
The last measure dose will be compared with the target dose in the 2022 Heart Failure Guidelines.
Measured: 6 months
Combined Emergency department visits and hospitalizations, as measured by number of subjects with at least one occurrence
Combined Emergency department visits and hospitalizations related to evidence-based medical therapies for HFrEF including symptomatic hypotension, hyperkalemia, and angioedema
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start2 Dec 2022
- Primary completion5 Mar 2025
- Study completion5 Mar 2025
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 Heart Failure With Reduced Ejection FractionStudies of the same condition, open and under way.
- More trials run by Duke 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Story Health Inc.
- Responsible party
- Sponsor
- Investigators
- Adam DeVore, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602454
- Sponsor's protocol ID
- Pro00110400
- Status last verified
- Jul 2025
- First submitted
- 27 Oct 2022
- Last updated
- 23 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khan MS, Sauer AJ, Green CL, McDermott J, Khan MS, Chaudhry SP, Haghighat AR, Bennett MK, Martyn T, Shah H, Govil A, Stanis T, Albert NM, DeVore AD. Rationale, design, and baseline characteristics of the virtual care to improve heart failure outcomes (VITAL-HF) trial. Am Heart J. 2025 Dec;290:46-57. doi: 10.1016/j.ahj.2025.06.001. Epub 2025 Jun 3.
PubMed 40473009
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Care to Improve Heart Failure Outcomes (VITAL-HF) Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05602454
- Acronym / sponsor ID
- Pro00110400
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Story Health Inc.
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 2 Nov 2022 (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 purpose of this study is to evaluate how safe and effective a remote, digital intervention is that helps clinicians use and optimally adjust heart failure medications, compared to usual care medication use and adjustment, in participants with heart failure with reduced ejection fraction
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital Heart Failure Medication Titration | Experimental | Other: Digital Heart Failure Medication TitrationThe Story Health platform will remotely receive daily vital signs directly from a blood pressure cuff and scale provided to the participant. Participants will also report any symptoms. All of this data will be transmitted, via the platform, to the treating clinician at the site, who will create care plans for medication titration and make clinical decisions. The care plans will be implemented with assistance from health coaches from Story Health Inc. |
| Usual Care | No intervention | –Routine clinical care will be followed. Participants will also receive a blood pressure cuff and scale, though the data will not be routinely fed back to the treating clinicians unless requested. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years of age
- Diagnosis of HF and LVEF <40% on most recent imaging assessment within 1 year prior to screening. Any validated method for assessing LVEF may be used for enrollment including echocardiogram, cardiac magnetic resonance imaging, etc. For participants with an LVEF reported qualitatively (e.g., moderate LV dysfunction) or as a range on the most recent imaging assessment that includes 40% (e.g., 35-45%), then the site investigator should review the imaging study and determine if the participant has an LVEF <40%. Participants with a new diagnosis of HFrEF may be enrolled. The enrollment will be monitored to ensure no more than 50% of the total cohort have new-onset HFrEF.
- Access to a smartphone including through a family member of caregiver
- Fluent in written and spoken English
Key exclusion criteria (9 listed)
- Optimized or nearly-optimized on evidence-based medical therapies for HFrEF as determined by local investigator.
- Current pregnancy
- Chronic use of intravenous inotropic medications including milrinone, dobutamine, or dopamine
- eGFR of <20 mL/min/1.73m2 or ongoing chronic dialysis at screening
- Prior heart transplant
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 |
|---|---|---|
| Digital Heart Failure Medication TitrationStory Health Platform, which is a remote, digital tool that provides treating clinicians collected data to make clinical decisions regarding heart failure medication titration. | Other | Digital Heart Failure Medication Titration |
Primary outcome
Change in medical therapy, as measured by the Heart Failure Medical Therapy Score
Time frame: Baseline, 6 months
Scores are 0-3 for 7 key medication classes for heart failure with reduced ejection fraction where 0 represents no use of the medication class
5 secondary outcomes
Change in medical therapy, as measured by the Kansas City Medical Optimization score
Time frame: Baseline, 6 months
Intensification of evidence-based medical therapies, measured by number of participants with reported changes.
Time frame: baseline, 6 months
Proportion of participants on 50% of published target doses of evidence-based medical therapies for HFrEF at last follow-up.
Time frame: 6 months
Proportion of participants on 100% of published target doses of evidence-based medical therapies for HFrEF at last follow-up.
Time frame: 6 months
Combined Emergency department visits and hospitalizations, as measured by number of subjects with at least one occurrence
Time frame: 3 months, 6 months
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 23 Jul 2025.
- Derived from this study: PubMed 40473009Khan MS, Sauer AJ, Green CL, McDermott J, Khan MS, Chaudhry SP, Haghighat AR, Bennett MK, Martyn T, Shah H, Govil A, Stanis T, Albert NM, DeVore AD. Rationale, design, and baseline characteristics of the virtual care to improve heart failure outcomes (VITAL-HF) trial. Am Heart J. 2025 Dec;290:46-57. doi: 10.1016/j.ahj.2025.06.001. Epub 2025 Jun 3.
- 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.
Adam DeVore, MD principal investigator
Duke University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Heart Failure Medication Titration in people with Heart Failure With Reduced Ejection Fraction, run by Duke University at 7 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 9 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 23 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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 medical therapy, as measured by the Heart Failure Medical Therapy Score (time frame: Baseline, 6 months). 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 NCT05602454, 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 23 Jul 2025.