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

Heart Failure With Reduced Ejection Fraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05602454
• Other study ID #: Pro00110400
• Status: Recruiting
• Phase: N/A
• Start date: December 2, 2022
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: Krista Camuglia
• Phone: 919-862-5967
• Email: krista.camuglia[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Reduced Ejection Fraction

Intervention

Other:
• Digital Heart Failure Medication Titration
Story Health Platform, which is a remote, digital tool that provides treating clinicians collected data to make clinical decisions regarding heart failure medication titration.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University	Durham	North Carolina
United States	Ascension St. Vincent	Indianapolis	Indiana
United States	Saint Luke's Health Systems	Kansas City	Missouri
United States	The University of Kansas Medical Center	Kansas City	Kansas
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Cardiovascular Institute of Northwest Florida	Panama City	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Story Health Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in participant-reported medication adherence using the Voils score	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.	Baseline, 6 months
Other	Change in Kansas City Cardiomyopathy Questionnaire Overall Summary score	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.	Baseline, 6 months
Other	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		baseline, 6 months
Other	Composite of all-cause death and total worsening HF events defined by hospitalizations for acute HF and urgent HF events		3 months, 6 months
Other	Worsening HF events defined by hospitalizations for acute HF and urgent HF events		3 months, 6 months
Other	All-cause hospitalizations		3 months, 6 months
Primary	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	Baseline, 6 months
Secondary	Change in medical therapy, as measured by the Kansas City Medical Optimization score	Scores are the average of the total daily dose to target dose values for HF medications. Scores range from 0-100.	Baseline, 6 months
Secondary	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.	baseline, 6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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	3 months, 6 months