Heart Failure Study to Evaluate Vital Signs and Overcome Low Use of Guideline-Directed Therapy by Remote Monitoring

NCT04292275 | Terminated

• 1 other identifier: 20180096
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 8

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.

Conditions

Heart Failure

Keywords

Digital health; Remote monitoring; Wearable device

Outcome Measures

Primary Outcomes (1)

• Time to Change or Decision That Heart Failure Therapy is Optimal

  Area under the curve (AUC) will be calculated for a daily dose-related medication score for beta-blocker, angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker/angiotensin neprilysin inhibitor, and aldosterone antagonist therapy.

  Randomization to 6 months

Secondary Outcomes (5)

• Time to change or decision that heart failure therapy is optimal

  Baseline to 6 months

• Numerical Health Information Technology Usability Evaluation Scale for Healthcare Provider Scores (Health-ITUES-HCP)

  Week 24

• Numerical Health Information Technology Usability Evaluation Scale for Participants (Health-ITUES-Subject) Scores

  Week 24

• Change in Numerical Rating of Subject Satisfaction with Heart Failure Therapy

  Baseline and Week 24

• Change from Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ-23) Scores

  Baseline and Week 24

Study Arms (2)

Digital Health Tools + Standard of Care

EXPERIMENTAL

Device: Biobeat Wrist Watch; Other: Standard of Care

Standard of Care

OTHER

Other: Standard of Care

Interventions

Biobeat Wrist Watch DEVICE

Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures. In addition, participants will be provided with a Biobeat wrist watch for continuous measurement and reporting of blood pressure data and with a smartphone to report weight.

Digital Health Tools + Standard of Care

Standard of Care OTHER

Standard of care procedures and therapies for managing heart failure will be carried out according to each investigator's standard procedures.

Digital Health Tools + Standard of Care; Standard of Care

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (8)

Yale New Haven Hospital

New Haven, Connecticut, 06520, United States

Location

Cardiology Associates of Fairfield County, PC

Stamford, Connecticut, 06905, United States

Location

MercyOne Northeast Iowa Family Medicine and Residency

Waterloo, Iowa, 50702, United States

Location

Virtua Health Inc.

Voorhees Township, New Jersey, 08043, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Diagnostic Cardiology Group

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Center for Clinical Trials, a division of Cardiology and Vascular Associates PLLC

Tullahoma, Tennessee, 37388, United States

Location

Inova Heart and Vascular Institute

Falls Church, Virginia, 22042, United States

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Heart Failure

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2020
• First Posted: March 3, 2020
• Study Start: March 6, 2020
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (8)