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Digital Intervention
Virtual Care for Heart Failure
N/A
Recruiting
Led By Adam DeVore, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months, 6 months
Awards & highlights
Study Summary
This trial will assess a digital intervention to help clinicians adjust heart failure meds, compared to usual care, to see if it's safe & effective.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves medication management rather than new drugs, side effects may be related to changes in existing medication regimens. These could include typical heart failure medication side effects like blood pressure changes, kidney function alterations, or electrolyte imbalances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I have heart failure with a heart function (LVEF) less than 40%.
Select...
I have been newly diagnosed with heart failure with reduced ejection fraction (HFrEF).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in medical therapy, as measured by the Heart Failure Medical Therapy Score
Secondary outcome measures
Change in medical therapy, as measured by the Kansas City Medical Optimization score
Combined Emergency department visits and hospitalizations, as measured by number of subjects with at least one occurrence
Intensification of evidence-based medical therapies, measured by number of participants with reported changes.
+2 moreOther outcome measures
All-cause hospitalizations
Cardiomyopathies
Change in participant-reported medication adherence using the Voils score
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Digital Heart Failure Medication TitrationExperimental Treatment1 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 CareActive Control1 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.
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Who is running the clinical trial?
Story Health Inc.UNKNOWN
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,419,889 Total Patients Enrolled
63 Trials studying Heart Failure
46,337 Patients Enrolled for Heart Failure
Adam DeVore, MDPrincipal InvestigatorDuke University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You currently have or are planning to get a left ventricular assist device.I regularly use medications like milrinone, dobutamine, or dopamine through an IV.My heart failure treatment is nearly at its best according to my doctor.I am currently in hospice care.I live in a facility where my food and medicine are managed by staff.I am older than 18 years.I have heart failure with a heart function (LVEF) less than 40%.You have had a heart transplant before.My kidney function is very low or I am on long-term dialysis.I have a terminal illness with less than 1 year to live, not including heart failure.I have been newly diagnosed with heart failure with reduced ejection fraction (HFrEF).
Research Study Groups:
This trial has the following groups:- Group 1: Digital Heart Failure Medication Titration
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers being accepted at this time for this research project?
"According to the info available on clinicaltrials.gov, this trial is still in its recruitment phase. It was initially posted in early December of 2022 and revised recently on the 5th day of that same month."
Answered by AI
What is the current enrollment quota for this clinical trial?
"Affirmative. According to clinicaltrials.gov, this medical study is currently enrolling patients as of December 5th 2022; the initial post for was on December 1st 2022 and it requires 180 participants from a single site."
Answered by AI
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