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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-06

Study Completion Date

2021-10-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Digital Health Tools + Standard of Care

Group Type EXPERIMENTAL

Biobeat Wrist Watch

Intervention Type 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.

Standard of Care

Intervention Type OTHER

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

Standard of Care

Group Type OTHER

Standard of Care

Intervention Type OTHER

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

Interventions

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Biobeat Wrist Watch

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.

Intervention Type DEVICE

Standard of Care

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No