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Trial Outcomes & Findings for The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure (NCT NCT00679549)

NCT ID: NCT00679549

Last Updated: 2019-05-14

Results Overview

Using the modified Simpson method. LVEF is calculated as (Left ventricular end diastolic volume (LVEDV)-left ventricular end systolic volume (LVESV)/left ventricular end diastolic volume (LVEDV) \*100. the measurement unit of LVEF is %.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

154 participants

Primary outcome timeframe

at baseline and 3 days post randomization

Results posted on

2019-05-14

Participant Flow

150 patients provided the baseline measurements and were randomized and included in the trial.

Participant milestones

Participant milestones
Measure
DEVICE
Provided CPAP as an inpatient CPAP Therapy: CPAP therapy is provided as an inpatient.
Control
No device provided
Overall Study
STARTED
75
75
Overall Study
COMPLETED
69
66
Overall Study
NOT COMPLETED
6
9

Reasons for withdrawal

Reasons for withdrawal
Measure
DEVICE
Provided CPAP as an inpatient CPAP Therapy: CPAP therapy is provided as an inpatient.
Control
No device provided
Overall Study
dropout
2
4
Overall Study
missing outcome echocardiograms
4
5

Baseline Characteristics

The Role of Sleep Apnea in the Acute Exacerbation of Heart Failure

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
DEVICE
n=75 Participants
Provided CPAP as an inpatient CPAP Therapy: CPAP therapy is provided as an inpatient.
Control
n=75 Participants
No device provided
Total
n=150 Participants
Total of all reporting groups
Age, Continuous
57 years
STANDARD_DEVIATION 11 • n=5 Participants
57 years
STANDARD_DEVIATION 13.5 • n=7 Participants
57 years
STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
21 Participants
n=7 Participants
43 Participants
n=5 Participants
Sex: Female, Male
Male
53 Participants
n=5 Participants
54 Participants
n=7 Participants
107 Participants
n=5 Participants
Race/Ethnicity, Customized
African American
18 Participants
n=5 Participants
17 Participants
n=7 Participants
35 Participants
n=5 Participants
Race/Ethnicity, Customized
White
57 Participants
n=5 Participants
58 Participants
n=7 Participants
115 Participants
n=5 Participants

PRIMARY outcome

Timeframe: at baseline and 3 days post randomization

Using the modified Simpson method. LVEF is calculated as (Left ventricular end diastolic volume (LVEDV)-left ventricular end systolic volume (LVESV)/left ventricular end diastolic volume (LVEDV) \*100. the measurement unit of LVEF is %.

Outcome measures

Outcome measures
Measure
DEVICE
n=69 Participants
Provided CPAP as an inpatient CPAP Therapy: CPAP therapy is provided as an inpatient.
Control
n=66 Participants
No device provided
Left Ventricular Ejection Fraction (LVEF)
Baseline
25.3 percent ejection fraction
Standard Deviation 10.6
27.0 percent ejection fraction
Standard Deviation 11.3
Left Ventricular Ejection Fraction (LVEF)
Conclusion
27.3 percent ejection fraction
Standard Deviation 11.9
28.8 percent ejection fraction
Standard Deviation 10.5

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 Unveristy

Phone: 6142477717

Results disclosure agreements

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