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Trial record 2 of 2 for:    109493

Influence of Sleep Apnea on Risk of Atrial Fibrillation (Safebeat)

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ClinicalTrials.gov Identifier: NCT02576587
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : August 15, 2018
Last Update Posted : August 15, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Reena Mehra, MD, The Cleveland Clinic

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Sleep Apnea
Atrial Fibrillation
Intervention: Other: Continuous Positive Airway Pressure

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Case (Diagnosed With PAF)

Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study.

Cases found to have an apnea hypopnea index >=15 will be asked to continue in the study for 3 months wearing a Continuous Positive Airway Pressure (CPAP) machine.

Continuous Positive Airway Pressure: For cases, those found to have moderate sleep apnea (AHI >=15) will be place on CPAP therapy.

Controls Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.

Participant Flow for 2 periods

Period 1:   Baseline
    Case (Diagnosed With PAF)   Controls
STARTED   161 [1]   156 [2] 
COMPLETED   161 [3]   155 [3] 
NOT COMPLETED   0   1 
Equipment failure                0                1 
[1] Total cases baseline visit
[2] Total controls baseline visit
[3] Baseline visit completed

Period 2:   Follow up Period (Case Only)
    Case (Diagnosed With PAF)   Controls
STARTED   161 [1]   155 [2] 
Selected for Follow up [3]   61   0 
COMPLETED   44   0 
NOT COMPLETED   117   155 
Withdrawal by Subject                25                0 
Not selected for follow up (AHI<15)                92                0 
Controls not eligible for followup                0                155 
[1] Completed baseline.
[2] Controls not eligible for follow-up
[3] Cases with apnea hypopnea index greater or equal to 15 were selected for follow up.



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Cases and controls completed baseline visit and having matched controls/cases were included in baseline analysis.

Reporting Groups
  Description
Case (Diagnosed With PAF)

Cases. Patients with Paroxysmal Atrial Fibrillation who present to Electrophysiology Clinic at UHCMC and the Cleveland Clinic Foundation will be approached for recruitment in the study.

Cases completed baseline and having matched controls were included in baseline data analysis.

Controls

Controls. Patients without AF will be recruited from General Cardiology and Internal Medicine clinics (geographically similar to controls). Selection bias will be minimized as there are a broad range of reasons for patients to present to these clinics.

Controls completed baseline and having matched cases were included in baseline data analysis.

Total Total of all reporting groups

Baseline Measures
   Case (Diagnosed With PAF)   Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 150   150   300 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   150   150   300 
   61  (12)   62  (12)   61  (12) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   150   150   300 
Female      55  36.7%      55  36.7%      110  36.7% 
Male      95  63.3%      95  63.3%      190  63.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed   150   150   300 
Hispanic or Latino      1   0.7%      1   0.7%      2   0.7% 
Not Hispanic or Latino      149  99.3%      149  99.3%      298  99.3% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed   150   150   300 
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      2   1.3%      2   1.3%      4   1.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      22  14.7%      22  14.7%      44  14.7% 
White      125  83.3%      125  83.3%      250  83.3% 
More than one race      1   0.7%      1   0.7%      2   0.7% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States       
Participants Analyzed   150   150   300 
United States   150   150   300 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
     
Participants Analyzed   150   150   300 
   31  (7)   32  (7)   31  (7) 
Apnea Hypopnea Index (AHI) [1] 
[Units: Apneas plus hypopneas per hour]
Median (Inter-Quartile Range)
     
Participants Analyzed   150   150   300 
   11 
 (4 to 24) 
 13 
 (4 to 24) 
 12 
 (4 to 24) 
[1]

AHI equals number of apnea and hypopnea breathing pauses divided by sleep duration in hours. It has a lower limit zero, but no upper limit. Greater AHI indicates higher severity of sleep apnea. The AHI values for adults are categorized as:

Normal: AHI<5; Mild sleep apnea: AHI greater than or equal to 5 and <15; Moderate sleep apnea: AHI greater than or equal to 15 and <30; Severe sleep apnea: any AHI value greater than or equal to 30.

In this study, cases having AHI greater than or equal to 15 qualifies for follow-up.

Arousal Index [1] 
[Units: Arousals per hour]
Median (Inter-Quartile Range)
     
Participants Analyzed   150   150   300 
   18 
 (13 to 26) 
 19 
 (13 to 28) 
 19 
 (13 to 27) 
[1] Arousal index (AI) equals number of arousals divided by sleep duration in hours. Arousals are interruptions of sleep lasting 3 to 15 seconds, spontaneously or as a result of sleep disordered breathing or other sleep disorders. It has a lower limit zero, but no upper limit. The range of AI for adults varies by age, e.g. 10-12/hour are normal at age 20, 20-22/hour are normal at age 50-60.
Central Apnea Index [1] 
[Units: Central apneas per hour]
Median (Inter-Quartile Range)
     
Participants Analyzed   150   150   300 
   0 
 (0 to 0.4) 
 0 
 (0 to 0.4) 
 0 
 (0 to 0.4) 
[1]

Central apnea index (CAI) equals number of central apneas divided by sleep duration in hours. Greater central apnea index indicates higher severity of sleep apnea. It has a lower limit zero, but no upper limit. The CAI values for adults are categorized as:

Normal: CAI<5; Mild sleep apnea: CAI greater than or equal to 5 and <15; Moderate sleep apnea: CAI greater than or equal to 15 and <30; Severe sleep apnea: any CAI value greater than or equal to 30.

Percent sleep time with oxygen saturation<90% 
[Units: Percent of sleep time]
Median (Inter-Quartile Range)
     
Participants Analyzed   150   150   300 
   0.4 
 (0 to 3) 
 0.4 
 (0 to 2) 
 0.4 
 (0 to 3) 
Left Atrial Volume [1] [2] 
[Units: mL]
Median (Inter-Quartile Range)
     
Participants Analyzed   135   135   270 
   63 
 (48 to 77) 
 51 
 (45 to 71) 
 60 
 (46 to 75) 
[1] Increased left atrial volume and strain are known risk factors of AF and PAF.
[2] Echocardiography measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.
Left Atrial Volume Index [1] [2] 
[Units: mL/m^2]
Median (Inter-Quartile Range)
     
Participants Analyzed   134   134   268 
   30 
 (23 to 37) 
 28 
 (22 to 33) 
 29 
 (23 to 35) 
[1]

Increased left atrial volume and strain are known risk factors of AF and PAF. Left atrial volume index (LAVI) is left atrial size indexed to Body surface area (BSA). The reference range of LAVI is 16-28 mL/m^2.

Mildly abnormal: 29-33 mL/m^2; Moderately abnormal: 34-39 mL/m^2; Severely abnormal: greater than or equal to 40 mL/m^2.

[2] Echocardiography measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.
Left Atrial Systolic Strain by apical four-chamber (A4C) view [1] [2] 
[Units: Percent of left atrial volume]
Median (Inter-Quartile Range)
     
Participants Analyzed   107   107   214 
   34 
 (25 to 40) 
 33 
 (27 to 41) 
 33 
 (27 to 41) 
[1] Left atrial systolic strain, a measure of left atrial remodeling which is inversely related to fibrosis in PAF, is measured by 2-dimensional echocardiography. Apical four-chamber and two-chamber views are the most commonly used approaches to measure the strain rate (%) of left atrial.
[2] Echocardiography measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.
Left Atrial Systolic Strain by apical two-chamber (A2C) view [1] [2] 
[Units: Percent of left atrial volume]
Median (Inter-Quartile Range)
     
Participants Analyzed   106   106   212 
   34 
 (29 to 41) 
 35 
 (29 to 43) 
 35 
 (29 to 42) 
[1] Left atrial systolic strain, a measure of left atrial remodeling which is inversely related to fibrosis in PAF, is measured by 2-dimensional echocardiography. Apical four-chamber and two-chamber views are the most commonly used approaches to measure the strain rate (%) of left atrial.
[2] Echo measurements were not available for some subjects due to image quality. If at least one of the matched case and control had missing value, this pair of subjects was not included in analysis.
High Blood Pressure or Hypertension 
[Units: Participants]
Count of Participants
     
Participants Analyzed   150   150   300 
   87   79   166 
High Blood cholesterol 
[Units: Participants]
Count of Participants
     
Participants Analyzed   150   150   300 
   86   91   177 
History of heart attack 
[Units: Participants]
Count of Participants
     
Participants Analyzed   150   150   300 
   9   16   25 
Depression 
[Units: Participants]
Count of Participants
     
Participants Analyzed   150   150   300 
   22   35   57 
Diabetes 
[Units: Participants]
Count of Participants
     
Participants Analyzed   150   150   300 
   19   23   42 
Use of Calcium blocker 
[Units: Participants]
Count of Participants
     
Participants Analyzed   150   150   300 
   20   8   28 
Use of beta blocker 
[Units: Participants]
Count of Participants
     
Participants Analyzed   150   150   300 
   85   35   120 
Any use of antihypertension medications [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   150   150   300 
   121   69   190 
[1] Medications included Ace Inhibitors, Antihypertensive, Alpha-2 Blocker, Beta-Blocker, Calcium blocker, Diuretic and Nitrates.


  Outcome Measures

1.  Primary:   Number of Participants With Paroxymal Atrial Fibrillation (PAF)   [ Time Frame: Baseline ]

2.  Secondary:   Echocardiography Measures- Left Atrial Volume   [ Time Frame: Baseline and 12 week follow up ]

3.  Secondary:   Echocardiographic Measures- LA Volume Index   [ Time Frame: Baseline and 12 week follow up ]

4.  Secondary:   Echocardiographic Measures- LA Systolic Strain by A4C View   [ Time Frame: Baseline and 12 week follow up ]

5.  Secondary:   Echocardiographic Measures- LA Systolic Strain by A2C View   [ Time Frame: Baseline and 12 week follow up ]

6.  Secondary:   Vascular Measures- Pulse Wave Velocity   [ Time Frame: Baseline and 12 week follow up ]

7.  Secondary:   Vascular Measures- Augmentation Index   [ Time Frame: Baseline and 12 week follow up ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Reena Mehra
Organization: Cleveland Clinic
phone: 216-444-4946
e-mail: mehrar@ccf.org



Responsible Party: Reena Mehra, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02576587     History of Changes
Other Study ID Numbers: 13-594
R01HL109493 ( U.S. NIH Grant/Contract )
First Submitted: October 8, 2015
First Posted: October 15, 2015
Results First Submitted: April 11, 2018
Results First Posted: August 15, 2018
Last Update Posted: August 15, 2018