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

Primary Purpose

Heart Failure With Reduced Ejection Fraction

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Heart Failure Medication Titration
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 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

Sites / Locations

  • Cardiovascular Institute of Northwest FloridaRecruiting
  • Ascension St. VincentRecruiting
  • The University of Kansas Medical CenterRecruiting
  • Minneapolis Heart Institute FoundationRecruiting
  • Saint Luke's Health SystemsRecruiting
  • Duke UniversityRecruiting
  • Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Digital Heart Failure Medication Titration

Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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

Full Information

First Posted
October 27, 2022
Last Updated
September 29, 2023
Sponsor
Duke University
Collaborators
Story Health Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05602454
Brief Title
Virtual Care to Improve Heart Failure Outcomes (VITAL-HF)
Official Title
Virtual Care to Improve Heart Failure Outcomes (VITAL-HF) Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 2, 2022 (Actual)
Primary Completion Date
November 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Story Health Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure With Reduced Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital Heart Failure Medication Titration
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Digital Heart Failure Medication Titration
Intervention Description
Story Health Platform, which is a remote, digital tool that provides treating clinicians collected data to make clinical decisions regarding heart failure medication titration.
Primary Outcome Measure Information:
Title
Change in medical therapy, as measured by the Heart Failure Medical Therapy Score
Description
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
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Intensification of evidence-based medical therapies, measured by number of participants with reported changes.
Description
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.
Time Frame
baseline, 6 months
Title
Proportion of participants on 50% of published target doses of evidence-based medical therapies for HFrEF at last follow-up.
Description
The last measure dose will be compared with the target dose in the 2022 Heart Failure Guidelines.
Time Frame
6 months
Title
Proportion of participants on 100% of published target doses of evidence-based medical therapies for HFrEF at last follow-up.
Description
The last measure dose will be compared with the target dose in the 2022 Heart Failure Guidelines.
Time Frame
6 months
Title
Combined Emergency department visits and hospitalizations, as measured by number of subjects with at least one occurrence
Description
Combined Emergency department visits and hospitalizations related to evidence-based medical therapies for HFrEF including symptomatic hypotension, hyperkalemia, and angioedema
Time Frame
3 months, 6 months
Other Pre-specified Outcome Measures:
Title
Change in participant-reported medication adherence using the Voils score
Description
The Voils score includes questions used to assess medication adherence. Answers range between "not at all" and "very much", with 3 options in between. "Not at all" means a dose was not missed and "Very much" means dose was missed for that reason.
Time Frame
Baseline, 6 months
Title
Change in Kansas City Cardiomyopathy Questionnaire Overall Summary score
Description
The Kansas City Cardiomyopathy Questionnaire 12-item version includes multiple domains: symptom frequency, quality of life, social limitation, and physical limitation. The Overall Summary score incorporates the averages of these 4 domains and is reported on a 0-to-100-point scale, where lower scores represent more severe symptoms and/or limitations and scores of 100 indicate no symptoms, no limitations, and excellent quality of life.
Time Frame
Baseline, 6 months
Title
Global rank score across 3 hierarchical tiers of a composite outcome: time to death, time to HF hospitalization, change from baseline to last follow-up in the HF medical therapy score
Time Frame
baseline, 6 months
Title
Composite of all-cause death and total worsening HF events defined by hospitalizations for acute HF and urgent HF events
Time Frame
3 months, 6 months
Title
Worsening HF events defined by hospitalizations for acute HF and urgent HF events
Time Frame
3 months, 6 months
Title
All-cause hospitalizations
Time Frame
3 months, 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krista Camuglia
Phone
919-862-5967
Email
krista.camuglia@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam DeVore, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Institute of Northwest Florida
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelley Sherk
Phone
850-769-0329
Email
ssherk@cvinwfl.com
First Name & Middle Initial & Last Name & Degree
Amir Haghighat, MD
Facility Name
Ascension St. Vincent
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Renick
Phone
317-338-6152
Email
anne.renick@ascension.org
First Name & Middle Initial & Last Name & Degree
Sunit-preet Chaudhry
Facility Name
The University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Becca Johnson
Phone
913-945-6442
Email
bjohnson35@kumc.edu
First Name & Middle Initial & Last Name & Degree
Hirak Shah, MD
Facility Name
Minneapolis Heart Institute Foundation
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cailin Oakes
Phone
612-863-5855
Email
cailin.oakes@allina.com
First Name & Middle Initial & Last Name & Degree
Mosi Bennett, MD
Facility Name
Saint Luke's Health Systems
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amanda Nesbitt
Phone
816-932-7985
Email
anesbitt@saint-lukes.org
First Name & Middle Initial & Last Name & Degree
Andrew Sauer, MD
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew Gray
Phone
919-681-1073
Email
matthew.gray@duke.edu
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Albert, PhD
Phone
216-444-7028
Email
albertn@ccf.org

12. IPD Sharing Statement

Plan to Share IPD
No

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

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