Trial Outcomes & Findings for Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events (NCT NCT04882449)

NCT ID: NCT04882449

Last Updated: 2025-02-10

Results Overview

Worsening HF will be defined as a composite of the following: urgent, unscheduled clinic or emergency department visit or hospital admission with a primary diagnosis of HF in which the patient exhibited new or worsening symptoms of HF on presentation, had objective evidence of new or worsening HF, and received initiation or intensification of treatment for HF.

• Recruitment status: COMPLETED
• Target enrollment: 329 participants
• Primary outcome timeframe: Approximately 1 year
• Results posted on: 2025-02-10

Participant Flow

Participant milestones

Measure	Bodyport Scale All subjects will be given the Bodyport scale to use Bodyport Scale: The Bodyport scale is capable of measuring key HF parameters of congestion and cardiac perfusion on a regular basis in a patient's home. These data will be combined into a composite index that may be used to identify patients at increased risk for decompensation, inform the reason for their decline, and offer the possibility to remotely optimize therapy to prevent further worsening HF.
Overall Study STARTED	329
Overall Study COMPLETED	329
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events

Baseline characteristics by cohort

Measure	Bodyport Scale n=329 Participants All subjects will be given the Bodyport scale to use Bodyport Scale: The Bodyport scale is capable of measuring key HF parameters of congestion and cardiac perfusion on a regular basis in a patient's home. These data will be combined into a composite index that may be used to identify patients at increased risk for decompensation, inform the reason for their decline, and offer the possibility to remotely optimize therapy to prevent further worsening HF.
Age, Continuous	64 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	142 Participants n=5 Participants
Sex: Female, Male Male	187 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	319 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	107 Participants n=5 Participants
Race (NIH/OMB) White	210 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Body Mass Index (BMI)	31.8 kg/m^2 STANDARD_DEVIATION 8.6 • n=5 Participants
Left Ventricular Ejection Fraction <=40%	183 Participants n=5 Participants
Left Ventricular Ejection Fraction 41-49%	25 Participants n=5 Participants
Left Ventricular Ejection Fraction >=50	118 Participants n=5 Participants
Left Ventricular Ejection Fraction Unknown	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 1 year

Worsening HF will be defined as a composite of the following: urgent, unscheduled clinic or emergency department visit or hospital admission with a primary diagnosis of HF in which the patient exhibited new or worsening symptoms of HF on presentation, had objective evidence of new or worsening HF, and received initiation or intensification of treatment for HF.

Outcome measures

Measure

Bodyport Scale n=329 Participants All subjects will be given the Bodyport scale to use Bodyport Scale: The Bodyport scale is capable of measuring key HF parameters of congestion and cardiac perfusion on a regular basis in a patient's home. These data will be combined into a composite index that may be used to identify patients at increased risk for decompensation, inform the reason for their decline, and offer the possibility to remotely optimize therapy to prevent further worsening HF.

Number of Usable Worsening HF Events as Adjudicated by CEC

69 Adjudicated Events

Adverse Events

Bodyport Scale

Serious events: 0 serious events

Other events: 0 other events

Deaths: 26 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dorothy Kwok, Head of Clinical Operations

Bodyport Inc.

Phone: 669-240-3077

Email: dorothy@bodyport.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER