Influence of Sleep Apnea on Risk of Atrial Fibrillation

NCT02576587 | Completed Results DMC

• 2 other identifiers: 13-594R01HL109493
• Study Type: interventional
• Target: 317
• Locations: 1 country
• Sites: 1

Brief Summary

The Elucidation of the Influence of Sleep Apnea on Risk of Atrial Fibrillation study. The study involves a case control design to investigate the extent to which there is an independent relationship of sleep disordered breathing (SDB) and paroxysmal atrial fibrillation (PAF). Cases will be defined as clinically identified patients with PAF and controls as those without AF. In order to rigorously address important biologic confounding influences, the cases and controls will be individually matched based upon age, gender, race, and body mass index. Those participants with both PAF and SDB (Apnea Hypopnea Index, AHI\>=15) will be asked to return for a follow up exam after 3 months of SDB treatment in the Clinical Research Unit (CRU) for collection of the same measures collected at the baseline exam to observe for any significant changes with the purpose of collecting effect size data to inform future clinical trials. The total duration of the study is 4 years. The duration for any individual participant is up to from one to 13 weeks months, including a 3-month treatment period for those with moderate to severe SDB, i.e. AHI\>15.

Conditions

Sleep Apnea; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Paroxymal Atrial Fibrillation (PAF)

  Patients with diagnosis of PAF were defined as cases. PAF is the primary outcome of baseline analysis, which aimed to quantify the association of sleep apnea and PAF.

  Baseline

Secondary Outcomes (6)

• Echocardiography Measures- Left Atrial Volume

  Baseline and 12 week follow up

• Echocardiographic Measures- LA Volume Index

  Baseline and 12 week follow up

• Echocardiographic Measures- LA Systolic Strain by A4C View

  Baseline and 12 week follow up

• Echocardiographic Measures- LA Systolic Strain by A2C View

  Baseline and 12 week follow up

• Vascular Measures- Pulse Wave Velocity

  Baseline and 12 week follow up

Study Arms (2)

Case (diagnosed with PAF)

OTHER

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.

Other: Continuous Positive Airway Pressure

Controls

NO INTERVENTION

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.

Interventions

Continuous Positive Airway Pressure OTHER

For cases, those found to have moderate sleep apnea (AHI \>=15) will be place on CPAP therapy.

Case (diagnosed with PAF)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• PAF defined by recurrent episodes of AF, which self-terminate within a 7-day period (based upon AHA consensus statement 77)
• Age 18-80 years
• Individuals able to participate in \> 2 overnight/daytime sleep and physiologic assessments over a 3 month period.
• Age 18 to 80 years
• Individuals in normal sinus rhythm (NSR) with no current AF or history of AF
• Individuals able to participate in an overnight/daytime sleep and physiologic assessment.

You may not qualify if:

• PAF with rapid or uncontrolled rate (\>120bpm)
• Post-operative PAF
• History of cardiac ablation or successful electro-cardioversion for PAF (ablation for other arrhythmias such as AVNRT and if PAF persists after cardioversion is acceptable )
• Valvular stenosis, prosthesis or significant valvular insufficiency \[i.e. those with moderate or greater severity of aortic stenosis (aortic valve area \<1.5 cm2), mitral regurgitation which is moderate or more severe in degree (\>20% regurgitant fraction) or moderate or greater severity mitral stenosis (mitral valve area \<1.5 cm2)\]
• Atrial septal defect
• Infiltrative/restrictive cardiomyopathy
• Sick sinus syndrome
• Previously diagnosed SDB on specific SDB treatments (CPAP, oral appliances)
• Severe chronic insomnia
• Circadian rhythm disorder (e.g. shift work sleep disorder, delayed or advanced sleep phase syndrome)
• Insufficient sleep syndrome defined by reported sleep duration \< 4 hrs
• Supplemental oxygen use
• Unstable medical conditions (e.g., new onset or changing angina, a myocardial infarction or congestive heart failure exacerbation documented within the previous 3 months, systolic heart failure (Left Ventricular Ejection Fraction \< 35%), high grade cardiac dysrhythmia/heart block, stroke with functional limitations, uncontrolled hypertension (BP\>170/110), abdominal aneurysm \>5.5 cm or \>1 cm growth/year, uncontrolled diabetes mellitus (HbA1c\>9.0), pulmonary hypertension, non-skin cancer diagnosis or treatment within the previous year, end stage renal and hepatic failure, immunodeficiencies (HIV, HCV), uncontrolled hypo- or hyperthyroidism)
• Psychiatric disorders which are inadequately treated
• Compromised competence

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• May AM, Wang L, Kwon DH, Van Wagoner DR, Chung MK, Dalton JE, Mehra R. Sleep apnea screening instrument evaluation and novel model development and validation in the paroxysmal atrial fibrillation population. Int J Cardiol Heart Vasc. 2020 Sep 4;31:100624. doi: 10.1016/j.ijcha.2020.100624. eCollection 2020 Dec.

  PMID: 33364332 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: Dr. Reena Mehra
• Organization: Cleveland Clinic

mehrar@ccf.org

216-444-4946

Study Officials

• Reena Mehra, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Sleep Disorders Reseach, Associate Professor of Medicine

Study Record Dates

• First Submitted: October 8, 2015
• First Posted: October 15, 2015
• Study Start: January 1, 2012
• Primary Completion: February 22, 2017
• Study Completion: February 22, 2017
• Last Updated: August 15, 2018
• Results First Posted: August 15, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)