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Recruiting
NCT05602454
Virtual Care to Improve Heart Failure Outcomes (VITAL-HF)
Conditions: Heart Failure With Reduced Ejection Fraction
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 180
Sponsor: Duke University
Location: United States
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
Eligibility Criteria
Inclusion Criteria:Age >18 years of ageDiagnosis 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 caregiverFluent in written and spoken EnglishExclusion Criteria:Optimized or nearly-optimized on evidence-based medical therapies for HFrEF as determined by local investigator.Current pregnancyChronic use of intravenous inotropic medications including milrinone, dobutamine, or dopamineeGFR of <20 mL/min/1.73m2
or ongoing chronic dialysis at screeningPrior heart transplantCurrent or planned left ventricular assist deviceCurrently receiving hospice careChronically resides in an assisted living or skilled nursing facility where food and medications are managed by facility personnelTerminal illness other than HF with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator
Source: ClinicalTrials.gov (NCT05602454). StuddyBuddy aggregates publicly available trial information.