Trial Outcomes & Findings for Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study (NCT NCT03195660)

NCT ID: NCT03195660

Last Updated: 2021-05-14

Results Overview

Average hours used per day

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-05-14

Participant Flow

Six participants overall were consented for the study, and baseline data on these participants was collected at the baseline visit. Following on from this, four participants did not meet the entry criteria for the study. Two participants started ASV therapy, but the study was terminated before the follow up period.

Participant milestones

Measure	ASV Therapy ASV Therapy ASV Therapy: AirCurve 10 ASV device set up in AutoSet mode
Overall Study STARTED	2
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	ASV Therapy ASV Therapy ASV Therapy: AirCurve 10 ASV device set up in AutoSet mode
Overall Study The study was terminated	2

Baseline Characteristics

Adherence to ASV Therapy in Heart Failure With Preserved Ejection Fraction Feasibility Study

Baseline characteristics by cohort

Measure	ASV Therapy n=6 Participants ASV Therapy ASV Therapy: AirCurve 10 ASV device set up in AutoSet mode
Age, Continuous	63 years n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants
Ejection fraction	64.5 percent n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: The study was terminated prior to the follow-up period

Average hours used per day

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: The study was terminated prior to the follow-up period

Change in KCCQ-12 score. Cardiomyopathy Questionnaire (Kansas City) (KCCQ-12) is a short questionnaire to evaluate quality of life in heart failure patients. All scores are scaled from 0-100 where low scares represent very poor health and high scores represent excellent health.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: The study was terminated prior to the follow-up period

Number of hospitalizations per subject

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Population: The study was terminated prior to the follow-up period

Number of deaths

Outcome measures

Outcome data not reported

Adverse Events

ASV Therapy

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

Adam Benjafield

ResMed

Phone: +61 466 634 609

Email: adam.benjafield@resmed.com

Results disclosure agreements

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