Trial Outcomes & Findings for Reassure Remote Respiration Monitoring in Heart Failure Patients (NCT NCT02624739)

NCT ID: NCT02624739

Last Updated: 2021-05-13

Results Overview

Number of successful data transmissions compared to number of possible data transmissions

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: One year
• Results posted on: 2021-05-13

Participant Flow

The study was terminated after enrollment but prior to data collection

Participant milestones

Measure	Intervention Reassure Non-Contact Respiration Monitor: Respiration parameters transmitted by the Reassure device will be evaluated daily by the study team and participants will be contacted for further evaluation if a change in respiration patterns is noted. Participants will continue with standard of care heart failure treatment. Reassure Non-Contact Respiration Monitor: Reassure uses a specially-designed, non-contact motion sensor to monitor body movement and continuous respiratory rate (CRR) during sleep. Reassure is used to monitor, over a prolonged period, the sleep patterns and respiration rate while the patient is asleep.	Control Reassure Non-Contact Respiration Monitor: Respiration parameters will be transmitted and stored, but there will be no active evaluation of respiration patterns. Participants will continue with standard of care heart failure treatment. Reassure Non-Contact Respiration Monitor: Reassure uses a specially-designed, non-contact motion sensor to monitor body movement and continuous respiratory rate (CRR) during sleep. Reassure is used to monitor, over a prolonged period, the sleep patterns and respiration rate while the patient is asleep.
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reassure Remote Respiration Monitoring in Heart Failure Patients

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: One year

Population: Study terminated prior to enrollment

Number of successful data transmissions compared to number of possible data transmissions

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: One year

Population: study terminated prior to enrollment

Quality of life as measured by Kansas City Cardiomyopathy Questionnaire

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: study terminated

Usability of the system by the clinical care team as measured by a System Usability Scale

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: study terminated

Trends in healthcare utilization and care patterns as measured by numbers of home visits, outpatient visits, all-cause hospitalizations, HF related hospitalizations, lengths of stay

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: study terminated

Percent compliance in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: study terminated

Rate of changes in HF-specific drugs: diuretics, ACE/ARB, Beta Blockers, Spironolactone/Nitrates and Hydralazine

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: study terminated

Trends in HF-specific biomarkers: NT-proBNP, ST2

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: study terminated

Retrospective exploratory analysis of respiration rate measured by the Reassure device compared to participant outcomes (eg, status at end of study, changes in medications, biomarkers, etc) to evaluate potential predictive trends for use in designing future studies.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: One year

Population: study terminated

Retrospective exploratory analysis of sleeping patterns measured by the Reassure device compared to participant outcomes (eg, status at end of study, changes in medications, biomarkers, etc) to evaluate potential predictive trends for use in designing future studies.

Outcome measures

Outcome data not reported

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Paul Phillips

ResMed

Phone: 01 906 8861

Email: paul.phillips@resmed.com

Results disclosure agreements

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