Heart Failure Clinical Trial

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

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

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Estimated Enrollment:

180

Study ID:

NCT05602454

Recruitment Status:

Recruiting

Sponsor:

Duke University

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There are 7 Locations for this study

See Locations Near You

Cardiovascular Institute of Northwest Florida
Panama City Florida, 32405, United States More Info
Shelley Sherk
Contact
850-769-0329
[email protected]
Amir Haghighat, MD
Principal Investigator
Ascension St. Vincent
Indianapolis Indiana, 46260, United States More Info
Anne Renick
Contact
317-338-6152
[email protected]
Sunit-preet Chaudhry
Principal Investigator
The University of Kansas Medical Center
Kansas City Kansas, 66160, United States More Info
Becca Johnson
Contact
913-945-6442
[email protected]
Hirak Shah, MD
Principal Investigator
Minneapolis Heart Institute Foundation
Minneapolis Minnesota, 55407, United States More Info
Cailin Oakes
Contact
612-863-5855
[email protected]
Mosi Bennett, MD
Principal Investigator
Saint Luke's Health Systems
Kansas City Missouri, 64111, United States More Info
Amanda Nesbitt
Contact
816-932-7985
[email protected]
Andrew Sauer, MD
Principal Investigator
Duke University
Durham North Carolina, 27710, United States More Info
Matthew Gray
Contact
919-681-1073
[email protected]
Cleveland Clinic
Cleveland Ohio, 44195, United States More Info
Nancy Albert, PhD
Contact
216-444-7028
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

180

Study ID:

NCT05602454

Recruitment Status:

Recruiting

Sponsor:


Duke University

How clear is this clinincal trial information?

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