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Trial Outcomes & Findings for Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure (NCT NCT00701038)

NCT ID: NCT00701038

Last Updated: 2013-02-04

Results Overview

Left ventricular function was assessed using doppler ultrasound. Positive increase in left ventricular function from baseline to 3 nights post treatment indicates potential beneficial impact of treatment on heart function.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

baseline and again after three nights in hospital

Results posted on

2013-02-04

Participant Flow

Participant milestones

Participant milestones
Measure
Device
Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
Control
No auto adjusting bi-level positive airway pressure device given during hospital stay
Overall Study
STARTED
27
27
Overall Study
COMPLETED
23
23
Overall Study
NOT COMPLETED
4
4

Reasons for withdrawal

Reasons for withdrawal
Measure
Device
Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
Control
No auto adjusting bi-level positive airway pressure device given during hospital stay
Overall Study
study amended pilot group of patients
4
4

Baseline Characteristics

Diagnosis and Treatment of Sleep Apnea in the Acute Exacerbation of Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Device
n=27 Participants
Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
Control
n=27 Participants
No auto adjusting bi-level positive airway pressure device given during hospital stay
Total
n=54 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
23 Participants
n=99 Participants
14 Participants
n=107 Participants
37 Participants
n=206 Participants
Age, Categorical
>=65 years
4 Participants
n=99 Participants
13 Participants
n=107 Participants
17 Participants
n=206 Participants
Age Continuous
62 years
STANDARD_DEVIATION 14 • n=99 Participants
51 years
STANDARD_DEVIATION 12 • n=107 Participants
56 years
STANDARD_DEVIATION 14 • n=206 Participants
Sex: Female, Male
Female
7 Participants
n=99 Participants
8 Participants
n=107 Participants
15 Participants
n=206 Participants
Sex: Female, Male
Male
20 Participants
n=99 Participants
19 Participants
n=107 Participants
39 Participants
n=206 Participants
Region of Enrollment
United States
27 participants
n=99 Participants
27 participants
n=107 Participants
54 participants
n=206 Participants

PRIMARY outcome

Timeframe: baseline and again after three nights in hospital

Population: ITT

Left ventricular function was assessed using doppler ultrasound. Positive increase in left ventricular function from baseline to 3 nights post treatment indicates potential beneficial impact of treatment on heart function.

Outcome measures

Outcome measures
Measure
Device
n=23 Participants
Provided with an auto adjusting bi-level positive airway pressure device for 3 days in hospital
Control
n=23 Participants
No auto adjusting bi-level positive airway pressure device given during hospital stay
Left Ventricular Ejection Fraction Improvement
4.5 percent change
Standard Error 1.7
-.3 percent change
Standard Error 1.5

Adverse Events

Device

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

Rami Khayat

The Ohio State Universtiy

Phone: 614-247-7707

Results disclosure agreements

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