Virtual Care for Heart Failure

No longer recruiting at 6 trial locations

Overseen By Krista Camuglia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Intravenous inotropes

Disqualifiers: Pregnancy, Dialysis, Heart transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital tool designed to help doctors adjust medications for people with heart failure and a reduced ejection fraction (a measure of how well the heart pumps blood). It compares the tool's use to usual care to determine its safety and effectiveness. Participants will use a blood pressure cuff and scale at home, providing their doctors with information to make better treatment decisions. This trial suits those diagnosed with heart failure with reduced ejection fraction and who own a smartphone. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve heart failure management.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. It focuses on adjusting heart failure medications, so you might need to change how you take them, but it's best to ask the trial team for details.

What prior data suggests that this digital intervention is safe for heart failure patients?

Research has shown that using digital tools to adjust heart failure medication is generally safe. One study found that managing heart failure treatment remotely did not increase the risk of high potassium levels or kidney problems compared to regular care. Another study demonstrated that adjusting medication remotely for people with reduced heart function was both effective and safe. These findings suggest that the digital approach in this trial should be well-tolerated by participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Heart Failure Medication Titration because it leverages technology to enhance patient care. Unlike traditional face-to-face consultations, this method uses the Story Health platform to remotely monitor daily vital signs and symptoms, ensuring clinicians have real-time data to make informed decisions. This innovative approach allows for more precise and timely adjustments to medication, potentially improving outcomes for heart failure patients. Additionally, the use of health coaches to support the implementation of care plans offers a personalized touch, empowering patients to manage their condition more effectively at home.

What evidence suggests that this digital intervention is effective for heart failure?

Research has shown that managing heart failure medications remotely can be very effective. In this trial, participants in the Digital Heart Failure Medication Titration arm will use a digital platform to manage their treatment. Studies have found that heart failure patients receiving recommended treatments through a digital platform often experience better health outcomes. Specifically, adjusting these medications remotely helps more patients safely and effectively reach their treatment goals. One study found that using a virtual system reduced hospital visits related to heart failure and improved important health indicators. This suggests that digital methods might be a promising way to manage heart failure more efficiently. ^{1 2 4 5 6}

Who Is on the Research Team?

Adam DeVore, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure and reduced ejection fraction (LVEF <40%) who have access to a smartphone. It's not for those in hospice care, pregnant, on certain heart failure therapies deemed optimal by the investigator, living in assisted facilities, using chronic IV heart medications, with prior heart transplants or severe kidney issues.

Inclusion Criteria

I am older than 18 years.

I have heart failure with a heart function (LVEF) less than 40%.

Fluent in written and spoken English

Exclusion Criteria

You currently have or are planning to get a left ventricular assist device.

Current pregnancy

I regularly use medications like milrinone, dobutamine, or dopamine through an IV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a remote, digital intervention to help clinicians use and optimally adjust heart failure medications

6 months

Remote monitoring with daily vital signs reporting

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Digital Heart Failure Medication Titration

Trial Overview The VITAL-HF study tests a digital intervention that helps doctors adjust heart failure medications remotely against usual care methods. The goal is to see if this virtual approach can safely improve outcomes for patients with reduced ejection fraction.

How Is the Trial Designed?

Group I: Digital Heart Failure Medication Titration Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 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 Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Story Health Inc.

Collaborator

Trials

1

Recruited

180+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1071916424005529

115 Effectiveness Of A Virtual Guideline Directed Medical ... Many studies have shown that heart failure (HF) patients who are promptly titrated on guideline-directed medical therapy (GDMT) experience improved outcomes ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12140189/

Pharmacist-led rapid uptitration clinic in heart failure ... Secondary outcomes. Over a 3-month follow-up period, hospitalisations related to heart failure were 8.1%, as evidenced by improvements in key ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05602454

Virtual Care to Improve Heart Failure Outcomes (VITAL-HF) 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 ...

4. jacc.org jacc.org/doi/10.1016/j.jchf.2024.02.008

The Effect of Using a Remote Patient Management ... Remote titration of GDMT in heart failure with reduced ejection fraction was effective, safe, feasible, and increased the proportion of patients achieving ...

5. nature.com nature.com/articles/s41591-024-03238-6

Digital consults in heart failure care: a randomized ... Abstract. Guideline-directed medical therapy (GDMT) has clear benefits on morbidity and mortality in patients with heart failure; however, GDMT ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213177924007984

Digital Solutions for the Optimization of Pharmacologic ... In this state-of-the-art review, we focus on digital interventions that specifically target the rapid initiation and titration of medical therapy for HF.