Virtual Care for Heart Failure

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

178 Participants Needed

Trial Summary

What is the purpose of this 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

Research Team

Adam DeVore, MD

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+