Heart Failure; With DecompensationELEVATE-HFNCT06592508
Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure
A study testing Remote Virtual Cardiology Program in people with Heart Failure; With Decompensation, run by Duke University at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate how safe and effective a remote, virtual, cardiology program is that provides heart failure education to patients, monitors for worsening heart failure, and quickly adjusts heart failure medications, compared to usual care medication use and adjustment, in participants with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure; With Decompensation
- What is being tested?
- Remote Virtual Cardiology Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 5 sitesUnited States
- Study dates
- 27 Sep 2024to 31 Mar 2026
- 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
- Acute decompensated HF as a primary cause of hospitalization. Hospitalizations for acute decompensated HF will be determined by local clinician-investigators but should include findings of acute HF (i.e., symptoms, signs, and/or laboratory/imaging abnormalities) and treatments aimed at acute HF (e.g., intravenous diuretics, vasodilators, or inotropes). Participants with a new diagnosis of HF may be enrolled. The enrollment will be monitored to ensure no more than 2/3 of the total cohort has new-onset HF.
- Fluent in written and spoken English
Who cannot join
- Optimized or nearly optimized on evidence-based medical therapies for HF 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 ongoing chronic dialysis at screening. The eGFR should be estimated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (2021 CKD-EPI) creatinine equation.
- History of prior heart transplant or currently listed for heart transplant
- Current left ventricular assist device or planned left ventricular assist device in the next 6 months
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- Currently receiving hospice care
- Chronically resides in an assisted living or skilled nursing facility where medications are managed by facility personnel
- Terminal illness other than HF with a life expectancy of <1 year as determined by the enrolling clinician-investigator
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Premier Health
Dayton, Ohio, 45409
Northeast Georgia Medical Center
Gainesville, Georgia, 30501
Cardiovascular Institute of Northwest Florida
Panama City, Florida, 32405
Duke Raleigh Hospital
Raleigh, North Carolina, 27609
ProMedica Toledo Hospital
Toledo, Ohio, 43615
About this study
Official title: Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure: The ELEVATE-HF Randomized Controlled Trial
The purpose of this study is to evaluate how safe and effective a remote, virtual, cardiology program is that provides heart failure education to patients, monitors for worsening heart failure, and quickly adjusts heart failure medications, compared to usual care medication use and adjustment, in participants with decompensated heart failure that are recently hospitalized.
- Conditions
- Heart Failure; With Decompensation
- Being tested
- Remote Virtual Cardiology Program
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Virtual Cardiology ProgramOther
Ventricle Health Program, which is a remote, virtual, cardiology program that provides heart failure education to patients, monitors for worsening heart failure, and rapidly titrates heart failure medical therapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Remote Virtual Cardiology Program | Experimental | The Ventricle Health program will remotely receive daily vital signs directly from a blood pressure cuff and scale provided to the participant. In addition, the program will also remotely receive oxygen levels and electrical heart activity directly from a Pulse Ox and an EKG Single-Lead monitor, provided to the participant. All of this data will be transmitted to the Ventricle Health program. The Ventricle Health team, consisting of Cardiologists and clinical staff, will use this data to titrate medications and make clinical decisions. Receives: Other: Remote Virtual Cardiology Program |
| Usual Care | No intervention | Routine clinical care will be followed. Participants should be recommended for the best possible outpatient heart failure care at each site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to all-cause death
Measured: Up to 120 days
Number of participants with worsening Heart Failure events
Measured: Up to 120 days
Time to first worsening Heart Failure event
Measured: Up to 120 days
Change in the number of classes of Heart Failure medications
Measured: Up to 120 days
Secondary outcomes (5)
Number of participants with any intensification (initiation or dose titration) of evidence-based medical therapies for HF (heart failure)
Measured: Baseline, 120 days
Cumulative number of intensifications of evidence-based medical therapies for HF (heart failure)
Measured: Baseline, 120 days
Change in the number of classes of HF (heart failure) medications
by different HF classifications as defined by LVEF
Measured: Baseline, 120 days
Composite of all-cause death and total worsening HF (heart failure) events defined by hospitalizations for acute decompensated HF and other urgent medical care for worsening HF
Measured: 30 day, 60 day, 120 day
Number of participants with combined Emergency department visits and hospitalizations
Combined Emergency department visits and hospitalizations related to evidence-based medical therapies for HF including symptomatic hypotension, hyperkalemia, and angioedema.
Measured: 30 day, 60 day, 120 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start27 Sep 2024
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure; With DecompensationStudies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Ventricle Health
- Responsible party
- Sponsor
- Investigators
- Adam DeVore, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06592508
- Sponsor's protocol ID
- Pro00115672
- Acronym
- ELEVATE-HF
- Status last verified
- May 2026
- First submitted
- 27 Aug 2024
- Last updated
- 29 May 2026
- 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 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of A Virtual Cardiology Program To Improve Outcomes After Acute Decompensated Heart Failure: The ELEVATE-HF Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06592508
- Acronym / sponsor ID
- ELEVATE-HF / Pro00115672
- Conditions
- Heart Failure; With Decompensation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Ventricle Health
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 19 Sep 2024 (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, virtual, cardiology program is that provides heart failure education to patients, monitors for worsening heart failure, and quickly adjusts heart failure medications, compared to usual care medication use and adjustment, in participants with decompensated heart failure that are recently hospitalized.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Remote Virtual Cardiology Program | Experimental | Other: Remote Virtual Cardiology ProgramThe Ventricle Health program will remotely receive daily vital signs directly from a blood pressure cuff and scale provided to the participant. In addition, the program will also remotely receive oxygen levels and electrical heart activity directly from a Pulse Ox and an EKG Single-Lead monitor, provided to the participant. All of this data will be transmitted to the Ventricle Health program. The Ventricle Health team, consisting of Cardiologists and clinical staff, will use this data to titrate medications and make clinical decisions. |
| Usual Care | No intervention | –Routine clinical care will be followed. Participants should be recommended for the best possible outpatient heart failure care at each site. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years of age
- Acute decompensated HF as a primary cause of hospitalization. Hospitalizations for acute decompensated HF will be determined by local clinician-investigators but should include findings of acute HF (i.e., symptoms, signs, and/or laboratory/imaging abnormalities) and treatments aimed at acute HF (e.g., intravenous diuretics, vasodilators, or inotropes). Participants with a new diagnosis of HF may be enrolled. The enrollment will be monitored to ensure no more than 2/3 of the total cohort has new-onset HF.
- Fluent in written and spoken English
Key exclusion criteria (9 listed)
- Optimized or nearly optimized on evidence-based medical therapies for HF 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 ongoing chronic dialysis at screening. The eGFR should be estimated using the 2021 Chronic Kidney Disease Epidemiology Collaboration (2021 CKD-EPI) creatinine equation.
- History of prior heart transplant or currently listed for 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 |
|---|---|---|
| Remote Virtual Cardiology ProgramVentricle Health Program, which is a remote, virtual, cardiology program that provides heart failure education to patients, monitors for worsening heart failure, and rapidly titrates heart failure medical therapy. | Other | Experimental: Remote Virtual Cardiology Program |
Primary outcome
Time to all-cause death
Time frame: Up to 120 days
Number of participants with worsening Heart Failure events
Time frame: Up to 120 days
Time to first worsening Heart Failure event
Time frame: Up to 120 days
Change in the number of classes of Heart Failure medications
Time frame: Up to 120 days
5 secondary outcomes
Number of participants with any intensification (initiation or dose titration) of evidence-based medical therapies for HF (heart failure)
Time frame: Baseline, 120 days
Cumulative number of intensifications of evidence-based medical therapies for HF (heart failure)
Time frame: Baseline, 120 days
Change in the number of classes of HF (heart failure) medications
Time frame: Baseline, 120 days
Composite of all-cause death and total worsening HF (heart failure) events defined by hospitalizations for acute decompensated HF and other urgent medical care for worsening HF
Time frame: 30 day, 60 day, 120 day
Number of participants with combined Emergency department visits and hospitalizations
Time frame: 30 day, 60 day, 120 day
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 29 May 2026.
- Individual participant dataSharing planned: No
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Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
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Acquisition of Cardiac Function Parameters in MRI and Echocardiography in Patients With Ethyltoxic Liver Cirrhosis and Transjugular Intrahepatic Portosystemic Shunt (TIPSS) Placement
MASLD, Liver Cirrhosis, Alcoholic
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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 principal investigator
Duke University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Virtual Cardiology Program in people with Heart Failure; With Decompensation, run by Duke University at 5 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 3 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 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Time to all-cause death (time frame: Up to 120 days). The study lists 4 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 29 May 2026.