Clinical trial NCT04292275: Heart Failure Study to Evaluate Vital Signs and Overcome Low Use of Guideline-Directed Therapy by Remote Monitoring
Official title: A Randomized, Open-Label, Standard-of-Care-Controlled, Multicenter Study to Evaluate Digital Health Data Use in Managing Guideline-Directed Heart Failure Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Heart Failure
Keywords: Digital health
Remote monitoring
Wearable device
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2020-03-03
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A study evaluating the impact of remotely collected data, measured using digital technologies, on the use of guideline-recommended heart failure therapy in adult participants with heart failure.


Eligibility criteria: Inclusion Criteria:

* History of chronic heart failure.
* Ejection fraction equal to or below 40%.
* New York Heart Association (NYHA) class II to class III.
* Enrollment during or within 30 days after a hospitalization, emergency department, or urgent, unscheduled clinic/office visit with primary diagnosis of heart failure.

Exclusion Criteria:

* Has received a major organ transplant (e.g., lung, liver, heart, bone marrow, kidney).
* Currently in an investigational device or drug study.
* Unwilling or unable to wear a digital wrist watch device for measuring blood pressure and other parameters during waking hours.

Primary outcomes:
measure: Time to Change or Decision That Heart Failure Therapy is Optimal
timeFrame: Randomization to 6 months
Secondary outcomes:
measure: Time to change or decision that heart failure therapy is optimal
timeFrame: Baseline to 6 months
measure: Numerical Health Information Technology Usability Evaluation Scale for Healthcare Provider Scores (Health-ITUES-HCP)
timeFrame: Week 24
measure: Numerical Health Information Technology Usability Evaluation Scale for Participants (Health-ITUES-Subject) Scores
timeFrame: Week 24
measure: Change in Numerical Rating of Subject Satisfaction with Heart Failure Therapy
timeFrame: Baseline and Week 24
measure: Change from Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Scores
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Stamford
country: United States
facility: Cardiology Associates of Fairfield County, PC
state: Connecticut
city: Waterloo
country: United States
facility: MercyOne Northeast Iowa Family Medicine and Residency
state: Iowa
city: Voorhees
country: United States
facility: Virtua Health Inc.
state: New Jersey
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Chattanooga
country: United States
facility: Diagnostic Cardiology Group
state: Tennessee
city: Tullahoma
country: United States
facility: Tennessee Center for Clinical Trials, a division of Cardiology and Vascular Associates PLLC
state: Tennessee
city: Falls Church
country: United States
facility: Inova Heart and Vascular Institute
state: Virginia
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: