Clinical trial NCT04519489: The Efficacy of PAP Therapy on Reducing AF Recurrence in Patients With Morbidity of OSA
Official title: The Efficacy of PAP Therapy on Reducing AF Recurrence in Patients With Morbidity of OSA: a Clinical Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Obstructive Sleep Apnea
Keywords: Recurrence
Positive Airway Pressure
Lead sponsor: Philips (China) Investment CO., LTD
Sponsor class: INDUSTRY
Collaborators: name: Peking University First Hospital
name: Beijing Tsinghua Changgeng Hospital
name: Beijing Tongren Hospital
name: Fu Wai Hospital, Beijing, China
name: Shanghai 6th People's Hospital
name: Ruijin Hospital
First posted: 2020-08-19
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to test the effectiveness of positive airway pressure therapy on reducing clinical failure after rhythm control treatment and restoring with regular heart beat in atrial fibrillation patients with obstructive sleep apnea.

Detailed description: This study aims to test the effectiveness of positive airway pressure therapy on reducing clinical failure after rhythm control treatment and restoring with regular heart beat in atrial fibrillation patients with obstructive sleep apnea. The study is designed as a multi-center randomized control trial, which plans to recruit 129 atrial fibrillation patients with obstructive sleep apnea (86 in the intervention group with atrial fibrillation standard care and positive airway pressure therapy, 43 in the control group with atrial fibrillation standard care but no positive airway pressure therapy). The subjects will in total visit the hospital 4 times during their 6 months follow-up period, at baseline, 1st, 3rd, and 6th month. Subjects will undergo questionnaire surveys and medical examinations at each visit. The primary objective is to compare after 6months, the clinical failure rate between the group with positive airway pressure therapy and the group with no positive airway pressure therapy.

Eligibility criteria: Inclusion Criteria:

* Symptomatic paroxysmal or persistent atrial fibrillation:

  1. Paroxysmal: at least having one episode every month for the last recent 6 months. Each episode with symptoms lasting for over 30 minutes and at least one episode is documented (≥30 seconds episode length, documented by ECG).
  2. Persistent: lasting over 7 days to 1 year persistent AF with ECG documented.
* Implement a rhythm control strategy, including:

  1. Ablation and restored on sinus rhythm after the procedure.
  2. Underwent medical or electrical cardioversion during hospitalization and restored on sinus rhythm before enrollment.
* OSA diagnosed with PSG test showing AHI≥10;
* 18 ≤ Age ≤ 75;
* Willing to participate in the study;
* Able to provide informed consent;
* Having access to smartphones and the internet, and be capable of using them.

Exclusion Criteria:

* BMI \> 30 kg/m2;
* LVEF ≤ 40% or HF with NYHA III/ IV;
* Other atrial arrhythmias, atrial flatter;
* Myocardial infarction;
* Hypertrophic Cardiomyopathy (HCM);
* Congenital heart disease;
* A clear diagnosis with heart valve diseases (including moderate-severe mitral stenosis/ insufficiency, moderate-severe aortic stenosis/ insufficiency);
* Hyperthyroidism heart disease;
* Other acute diseases leading to temporary AF;
* In surgery perioperative period;
* Accepted other cardiothoracic surgery except for ablation;
* PSG test showing mainly central apneas (Cheyne-Stokes breathing);
* Pulmonary diseases causing dyspnea at rest or on minimal exertion;
* With other active major organ system disease that is not suitable for study participation, such as cancer, severe liver diseases, severe kidney diseases, etc.;
* With significantly impaired cognitive function, having severe problems in learning, memory, perception, and problem solving, and are unable to understand or not be competent to the informed consent;
* Having already accepted treatment to the sleep apnea syndrome;
* Having received intervention in any other trial within 30 days prior to the planned recruitment.

Primary outcomes:
measure: Number of participants with documented AFib recurrence
timeFrame: From baseline to the event occurs, up to 6 months.
Secondary outcomes:
measure: Change from baseline in atrial fibrillation burden at 6 months
timeFrame: Baseline, the 6th month.
measure: Changes from baseline in self-rated AF symptoms at 1 month, 3 months and 6 months.
timeFrame: Baseline, the 1st month, 3rd month and 6th month.
measure: Changes from baseline in quality of life at 3 months and 6 months.
timeFrame: Baseline, the 3rd month and 6th month.
measure: Changes from baseline in daytime sleepiness at 1 month, 3 months and 6 months.
timeFrame: The 1st month, 3rd month and 6th month.
measure: Other cardiovascular events
timeFrame: From baseline to the event occurs, up to 6 months.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
affiliation: Beijing Tsinghua Changgeng Hospital
name: Jingying Ye, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University First Hospital
name: Yong Huo, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yaranov DM, Smyrlis A, Usatii N, Butler A, Petrini JR, Mendez J, Warshofsky MK. Effect of obstructive sleep apnea on frequency of stroke in patients with atrial fibrillation. Am J Cardiol. 2015 Feb 15;115(4):461-5. doi: 10.1016/j.amjcard.2014.11.027. Epub 2014 Nov 29.
citation: Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946.
citation: January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JC Jr, Ellinor PT, Ezekowitz MD, Field ME, Furie KL, Heidenreich PA, Murray KT, Shea JB, Tracy CM, Yancy CW. 2019 AHA/ACC/HRS Focused Update of the 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Rhythm Society in Collaboration With the Society of Thoracic Surgeons. Circulation. 2019 Jul 9;140(2):e125-e151. doi: 10.1161/CIR.0000000000000665. Epub 2019 Jan 28. No abstract available.
citation: Li L, Wang ZW, Li J, Ge X, Guo LZ, Wang Y, Guo WH, Jiang CX, Ma CS. Efficacy of catheter ablation of atrial fibrillation in patients with obstructive sleep apnoea with and without continuous positive airway pressure treatment: a meta-analysis of observational studies. Europace. 2014 Sep;16(9):1309-14. doi: 10.1093/europace/euu066. Epub 2014 Apr 2.
citation: Shukla A, Aizer A, Holmes D, Fowler S, Park DS, Bernstein S, Bernstein N, Chinitz L. Effect of Obstructive Sleep Apnea Treatment on Atrial Fibrillation Recurrence: A Meta-Analysis. JACC Clin Electrophysiol. 2015 Mar-Apr;1(1-2):41-51. doi: 10.1016/j.jacep.2015.02.014. Epub 2015 Apr 20.
citation: Qureshi WT, Nasir UB, Alqalyoobi S, O'Neal WT, Mawri S, Sabbagh S, Soliman EZ, Al-Mallah MH. Meta-Analysis of Continuous Positive Airway Pressure as a Therapy of Atrial Fibrillation in Obstructive Sleep Apnea. Am J Cardiol. 2015 Dec 1;116(11):1767-73. doi: 10.1016/j.amjcard.2015.08.046. Epub 2015 Sep 12.
citation: Nalliah CJ, Sanders P, Kalman JM. Obstructive Sleep Apnea Treatment and Atrial Fibrillation: A Need for Definitive Evidence. J Cardiovasc Electrophysiol. 2016 Aug;27(8):1001-10. doi: 10.1111/jce.12981. Epub 2016 May 31.
citation: Craig S, Pepperell JC, Kohler M, Crosthwaite N, Davies RJ, Stradling JR. Continuous positive airway pressure treatment for obstructive sleep apnoea reduces resting heart rate but does not affect dysrhythmias: a randomised controlled trial. J Sleep Res. 2009 Sep;18(3):329-36. doi: 10.1111/j.1365-2869.2008.00726.x. Epub 2009 Jun 22.
citation: Copur AS, Erik Everhart D, Zhang C, Chen Z, Shekhani H, Mathevosian S, Loveless J, Watson E, Kadri I, Wallace L, Simon E, Fulambarker AM. Effect of personality traits on adherence with positive airway pressure therapy in obstructive sleep apnea patients. Sleep Breath. 2018 May;22(2):369-376. doi: 10.1007/s11325-017-1559-5. Epub 2017 Aug 30.
citation: Kirchhof P, Benussi S, Kotecha D, Ahlsson A, Atar D, Casadei B, Castella M, Diener HC, Heidbuchel H, Hendriks J, Hindricks G, Manolis AS, Oldgren J, Popescu BA, Schotten U, Van Putte B, Vardas P; ESC Scientific Document Group. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur Heart J. 2016 Oct 7;37(38):2893-2962. doi: 10.1093/eurheartj/ehw210. Epub 2016 Aug 27. No abstract available.
citation: Hurst NP, Kind P, Ruta D, Hunter M, Stubbings A. Measuring health-related quality of life in rheumatoid arthritis: validity, responsiveness and reliability of EuroQol (EQ-5D). Br J Rheumatol. 1997 May;36(5):551-9. doi: 10.1093/rheumatology/36.5.551.
citation: Netzer NC, Stoohs RA, Netzer CM, Clark K, Strohl KP. Using the Berlin Questionnaire to identify patients at risk for the sleep apnea syndrome. Ann Intern Med. 1999 Oct 5;131(7):485-91. doi: 10.7326/0003-4819-131-7-199910050-00002.
citation: Kilicaslan F, Verma A, Saad E, Themistoclakis S, Bonso A, Raviele A, Bozbas H, Andrews MW, Beheiry S, Hao S, Cummings JE, Marrouche NF, Lakkireddy D, Wazni O, Yamaji H, Saenz LC, Saliba W, Schweikert RA, Natale A. Efficacy of catheter ablation of atrial fibrillation in patients with hypertrophic obstructive cardiomyopathy. Heart Rhythm. 2006 Mar;3(3):275-80. doi: 10.1016/j.hrthm.2005.11.013.
citation: Becker PH, Sperveslage H. Organochlorines and heavy metals in herring gull (Larus argentatus) eggs and chicks from the same clutch. Bull Environ Contam Toxicol. 1989 May;42(5):721-7. doi: 10.1007/BF01700394. No abstract available.