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

NCT02727192 | Completed Results DMC

• 1 other identifier: Gullestad
• Study Type: interventional
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Disordered Breathing; Sleep Apnea; Paroxysmal Atrial Fibrillation

Keywords

Atrial fibrillation; CPAP; Sleep apnea; Sleep disordered breathing

Outcome Measures

Primary Outcomes (1)

• Change in AF Burden

  Difference between PAP 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 five month intervention period.

  Baseline (pre-randomization) was the first month of loop recorder data collection and was compared to the last three months of the intervention period.

Secondary Outcomes (17)

• Change in AF Burden

  Baseline to the last month of intervention period

• Change in AF Burden

  Comparing Baseline to the last five months of the intervention period

• Number of Participants With More Than 25% Reduction in AF Burden

  Baseline to last three months of the intervention

• Change of Recurrence Rate After Ablation, as Measured by Loop Recorder

  12 months

• Change in AF Symptoms as Assessed by Atrial Fibrillation Severity Scale (AFSS)

  6 months, 12 months and 18 months

Study Arms (2)

PAP-therapy (CPAP or ASV)

ACTIVE COMPARATOR

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)

Control group

NO INTERVENTION

No sleep apnea treatment

Interventions

PAP (CPAP or ASV) DEVICE

Patients will be randomized to treatment of Sleep Apnea with a CPAP or control

PAP-therapy (CPAP or ASV)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• Norwegian Health Association: collaborator
• Medtronic: collaborator
• ResMed: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

Related Publications (2)

• Traaen GM, Aakeroy L, Hunt TE, Overland B, Bendz C, Sande LO, Aakhus S, Fagerland MW, Steinshamn S, Anfinsen OG, Massey RJ, Broch K, Ueland T, Akre H, Loennechen JP, Gullestad L. Effect of Continuous Positive Airway Pressure on Arrhythmia in Atrial Fibrillation and Sleep Apnea: A Randomized Controlled Trial. Am J Respir Crit Care Med. 2021 Sep 1;204(5):573-582. doi: 10.1164/rccm.202011-4133OC.

  PMID: 33938787 DERIVED

• Traaen GM, Aakeroy L, Hunt TE, Overland B, Lyseggen E, Aukrust P, Ueland T, Helle-Valle T, Steinshamn S, Edvardsen T, Khiabani Zare H, Aakhus S, Akre H, Anfinsen OG, Loennechen JP, Gullestad L. Treatment of sleep apnea in patients with paroxysmal atrial fibrillation: design and rationale of a randomized controlled trial. Scand Cardiovasc J. 2018 Dec;52(6):372-377. doi: 10.1080/14017431.2019.1567933. Epub 2019 Feb 5.

  PMID: 30638392 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Atrial Fibrillation

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Professor Lars Gullestad
• Organization: Oslo University Hospital

lars.gullestad@medisin.uio.no

+4797644772

Study Officials

• Lars Gullestad, MD PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor MD

Study Record Dates

• First Submitted: March 29, 2016
• First Posted: April 4, 2016
• Study Start: January 21, 2016
• Primary Completion: July 1, 2019
• Study Completion: September 1, 2020
• Last Updated: June 22, 2021
• Results First Posted: June 22, 2021

Record last verified: 2021-05

Locations

NO (1)