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Effect of Treatment of Sleep Apnea in Patients With Paroxysmal Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT02727192
Recruitment Status : Active, not recruiting
First Posted : April 4, 2016
Last Update Posted : December 10, 2019
Sponsor:
Collaborators:
Norwegian Health Association
Medtronic
ResMed
Information provided by (Responsible Party):
Lars Gullestad, Oslo University Hospital

Brief Summary:
Atrial fibrillation (AF) is the most common cardiac rhythm disturbance in adults, with prevalence expected to rise significantly the coming decades. The occurrence of AF is associated with significantly increased mortality as well as morbidity of which cerebrovascular accidents is the most important. Unfortunately treatment options remain limited. Anti-arrhythmic drugs are widely used but have limited efficacy and the potential for toxicity and adverse events are recognized. Recent year's catheter ablation of AF continues to gain acceptance for symptomatic treatment, but recurrence rate are high with need for continuous medication. Thus there is a need to better understand what causes development and triggers episodes of AF as well to introduce new treatment options. Cardiometabolic factors such as obesity, inactivity and sleep apnea (SA) have therefore gained interest. Many patients with AF have chronic sleep apnea, and in the present study the investigators want to explore the interaction between SA and AF. The hypothesis of the present study is that SA may trigger AF and that treatment of SA will reduce the overall burden of AF as well as reduce the recurrence of AF after pulmonary vein ablation. To test the hypothesis the investigators will implant a Reveal device that continuously records the hearts rhythm of 100 patients with paroxysmal AF and concomitant SA. Initially the influence of SA on onset of AF will be examined, and the patients will then be randomized to treatment of SA or not and the influence on total AF burden recorded both before and after ablation.

Condition or disease Intervention/treatment Phase
Sleep Disordered Breathing Sleep Apnea Paroxysmal Atrial Fibrillation Device: PAP (CPAP or ASV) Not Applicable

Detailed Description:

For the present project the investigators have established a research team from 2 different university hospitals. This team, including high ranked, internationally renowned scientist from both clinical and basic sciences, will make a framework for PhD candidates and will ensure the patient cohort. Patients with paroxysmal AF and SA will be examined with an extensive diagnostic battery including advanced cardiac imaging tools allowing a proper description of the heart. Then a Reveal that continuously monitor the rhythm of the heart will be inserted, allowing the influence of SA, physical activity, inflammatory parameters, and other external variables on total AF burden to be examined. The patients will then be randomized to treatment of SA with a CPAP or not, and the AF burden recorded 6 months before ablation and 6 months after.

The present investigations carried out, are expected to results in better understanding of the interaction between AF and SA and may lay the scientific basis for better diagnostic and therapeutic approaches for patients with AF. In addition, given the advantage of continuous Reveal® recording of the patient's heart rhythm, the present study will examine possible triggers of AF such as activity level and inflammatory substances, and examine the role of structural abnormalities in the heart as assessed by echocardiography for the triggering of AF episodes. An overall aim is therefore a better phenotyping of the patient which could aid in a more person-specific treatment approach, with direct consequences both for the individual patient and for the society.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sleep Disordered Breathing in Patients With Paroxysmal Atrial Fibrillation
Actual Study Start Date : January 21, 2016
Actual Primary Completion Date : July 1, 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PAP-therapy (CPAP or ASV)
Patients are randomized to either intervention Group: Positive airway pressure therapy (PAP-therapy) or Control. Patients in the intervention arm will be treated with PAP-therapy (Continous Positive Airway Pressure (CPAP) or Adaptive Servo Ventilation (ASV).
Device: PAP (CPAP or ASV)
Patients will be randomized to treatment of Sleep Apnea with a CPAP or control

No Intervention: Control group
No sleep apnea treatment



Primary Outcome Measures :
  1. Change in AF burden [ Time Frame: Baseline to last three months (6 months) ]
    Difference between CPAP treatment and usual care in change of AF burden (% of time in AF, as measured by loop recorder) from baseline (one month prior to randomization) to the last three months of the intervention period.


Secondary Outcome Measures :
  1. Change in AF burden [ Time Frame: Baseline to last month (6 months) ]
    Difference between CPAP treatment and usual care in change of AF burden (% of time in AF, as measured by loop recorder) from baseline (one month prior to randomization) to the last month of the intervention period.

  2. Change in AF burden [ Time Frame: Baseline to last five months (6 months) ]
    Difference between CPAP treatment and usual care in change of AF burden (% of time in AF, as measured by loop recorder) from baseline (one month prior to randomization) to the last five months of the intervention period.

  3. Proportion with more than 25% reduction in AF burden [ Time Frame: Baseline to last three months (6 months) ]
    Difference between CPAP treatment and usual care in the proportion of patients with at least 25% reduction of AF burden (% of time in AF, as measured by loop recorder) from baseline (one month prior to randomization) to the last three months of the intervention period.

  4. Change of recurrence rate after ablation, as measured by loop recorder [ Time Frame: 12 months ]
    Change of recurrence rate after ablation, as measured by loop recorder, after 6 months post ablation and after 12 months post ablation.

  5. Change in AF symptoms as assessed by Atrial Fibrillation severity scale (AFSS) [ Time Frame: 6 months, 12 months and 18 months ]
    Change in AF symptoms between CPAP treatment and usual care. The questionnaire quantifies three domains of AF: event frequency (score 1-10), duration (score 1-10), and global episode severity (score 1-10). The total AF burden is calculated from the modified sum of the frequency, duration, and severity of AF (score 3-30, with higher scores indicating greater AF burden ). In addition, the AFSS assesses a symptom score based on seven items asking how bothered patients are by specified symptoms (score 0-35). Global well-being is a visual analogue scale ranging from 1 to 10 (10 indicating the best possible life).

  6. Change in quality of Life (QoL) as assessed by Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) [ Time Frame: 6 months, 12 months and 18 months ]
    Difference between CPAP and usual care in QoL as assessed by SF36, Version 1.2. Item scores are transformed into the Physical and Mental Component Summary scores (PCS and MCS). Scores range from 0 to 100, with higher scores indicating a better health state.

  7. Change in sleep quality and symptoms of sleep apnea: Epworth Sleepiness Scale (ESS) score [ Time Frame: 6 months, 12 months and 18 months ]
    Change in sleep quality and symptoms of obstructive sleep apnea as measured using the Epworth Sleepiness Scale (ESS) score, with scores ranging from 0 to 24 (most sleepy)

  8. Change in symptoms of obstructive sleep apnea [ Time Frame: 6 months, 12 months and 18 months ]
    Change in sleep quality and symptoms of obstructive sleep apnea as measured using the Berlin Questionnaire. Positive scores in two or more categories suggest a high risk of OSA.

  9. Change in symptoms of sleep apnea [ Time Frame: 6 months, 12 months and 18 months ]
    Change in sleep quality and symptoms of obstructive sleep apnea as measured using the Functional Outcomes of Sleep Questionnaire (FOSQ). Score range is 5-20 Points, with higher scores indicating better functional status.

  10. Change in symptoms of sleep apnea measured by the STOP-Bang [ Time Frame: 6 months, 12 months and 18 months ]
    Change in sleep quality and symptoms of obstructive sleep apnea as measured using the STOP-Bang Questionnaire. Score between 0-8. A score of ≥3 suggest risk for OSA.

  11. Examine the effect of SA treatment on inflammatory and anti-inflammatory biomarkers in plasma and serum [ Time Frame: 6 months, 12 months and 18 months ]
    CRP, TNF-ALFA, Interleukin, anti-inflammatory chemokines, endothelial function and metallproteinases

  12. Examine the effect of SA treatment on Cardiac structure and function as assessed by ecco [ Time Frame: 6 months, 12 months and 18 months ]
    Examine the effect of SA treatment on Cardiac structure and function as assessed by ecco

  13. Examine the effect of SA treatment on the Cardiac markers of troponin T and NT-proBNP. [ Time Frame: 6 months, 12 months ]
    Examine the effect of SA treatment on the Cardiac markers of troponin T and NT-proBNP.

  14. Examine the effect of SA treatment on gene Expression of white blood cells. [ Time Frame: 6 months and 12 months ]
    Examine the effect of SA treatment on gene Expression of white blood cells. Is paroxysmal AF Associated with specific gene Expression patterns? Examine the influence of SA treatment on the pattern of gene Expression and if this is related to reduction of atrial fibrillation burden

  15. Examine if onset of paroxysmal AF is Associated with specific Activity patterns, as assessed by garmin Vivofit2/3, Activity recording [ Time Frame: 6 months and 12 months ]
    Examine if onset of paroxysmal AF is Associated with specific Activity patterns, as assessed by garmin Vivofit2/3, Activity recording

  16. Change in body composition as assessed by Bioelectric Impedance Analysis (BIA) (Tanita) [ Time Frame: 6 months and 12 months ]
    Change in body composition as assessed by Bioelectric Impedance Analysis (BIA) (Tanita)

  17. Lung function test as assessed by spirometry [ Time Frame: At screening ]
    Lung function test as assessed by spirometry



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-75 years
  • Male or female
  • Patients with paroxysmal AF scheduled for first or second catheter ablation
  • Moderate-to-severe SA defined as an AHI ≥15/h (OSA and/or CSA)
  • Signed informed consent

Exclusion Criteria:

  • Unstable patients
  • Patients with left ventricular ejection fraction (LV-EF) < 45%
  • Unstable coronary artery disease, myocardial infarction or PCI within 3 months prior to the study
  • Bypass surgery within 6 months prior to the study
  • Patients with TIA or stroke within the previous 3 months
  • BMI > 40kg/m2
  • Drowsy drivers and/or sleepy patients with ESS (Epworth Sleepiness Score) > 15
  • Patients with interstitial lung diseases, severe obstructive lung defects, and thoracic myopathies or severe obstructive lung defects with FEV1 < 50% of predicted
  • Oxygen saturation < 90% at rest during the day
  • Poor compliance
  • Patients with single chamber pacemaker (or ICD)
  • Current use of PAP therapy
  • Patients using amiodarone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02727192


Locations
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Norway
Oslo University Hospital
Oslo, Norway, 0424
Sponsors and Collaborators
Oslo University Hospital
Norwegian Health Association
Medtronic
ResMed
Investigators
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Principal Investigator: Lars Gullestad, MD PhD Oslo University Hospital
  Study Documents (Full-Text)

Documents provided by Lars Gullestad, Oslo University Hospital:
Statistical Analysis Plan  [PDF] November 29, 2019


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lars Gullestad, Professor MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT02727192     History of Changes
Other Study ID Numbers: Gullestad
First Posted: April 4, 2016    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019
Keywords provided by Lars Gullestad, Oslo University Hospital:
Atrial fibrillation
CPAP
Sleep apnea
Sleep disordered breathing
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Respiratory Aspiration
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases