Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study

Not Applicable

Recruiting

• Conditions: Atrial Fibrillation; Obstructive Sleep Apnea
• Interventions: Device: Delayed enhancement magnetic resonance imaging (DE-MRI)

• Registration Number: NCT04814420
• Lead Sponsor: Tulane University

Brief Summary

The investigators hypothesize that Obstructive Sleep Apnea (OSA) is an independent risk factor for atrial fibrosis development. The investigators aim to prove the presence of atrial fibrosis on Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) in OSA patients without atrial fibrillation (AF).

Detailed Description

This is a cross sectional pilot study. Sixty mild to severe OSA patients and five age- and Body Mass Index (BMI)-matched controls will undergo a DE-MRI. Demographics, medical history and polysomnography results will be collected. Patients diagnosed with obstructive sleep apnea have undergone a polysomnography before the study and were diagnosed based on this test. The investigators will not be performing a polysomnography for any of the patients, just collecting the previous results from their medical charts to confirm they have a true OSA diagnosis for their inclusion in the study.

Study Timeline

• Study First Submitted: 2021-03-22
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-24
• Study Start: 2021-07-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Group A: 10 patients 18-75-year-old With mild OSA (5<AHI<15), confirmed by polysomnography. No previous AF diagnosis on the medical chart

Group B: 10 patients 18-75-year-old With moderate OSA (15<AHI<30), confirmed by polysomnography. No previous AF diagnosis on the medical chart

Group C: 10 patients 18-75-year-old With severe OSA (AHI>30), confirmed by polysomnography. No previous AF diagnosis on the medical chart

Group D (mild OSA+ AF): 10 patients 18-75-year-old With mild OSA (5<AHI<15), confirmed by polysomnography. Previous AF diagnosis

• In this group, patients with AF and OSA who already have done MRI might be included.

Group E (severe OSA +AF): 10 patients 18-75-year-old With severe OSA (AHI>30), confirmed by polysomnography. Previous AF diagnosis

*In this group, patients with AF and OSA who already have done MRI might be included.

Group F (Control): 10 Patients 18-75-year-old No previous OSA and/or AF Diagnosis on the medical chart

Exclusion Criteria

• History of chronic heart failure (LVEF < 50%), AF, myocardial infarction, valvular disease.
• Prior cardiac or chest surgery.
• Other advanced pulmonary disease (severe Chronic Obstructive Pulmonary Disease (COPD) or asthma, pulmonary hypertension) or central sleep apnea.
• Contraindications to DE-MRI (e.g. allergy to gadolinium, pacemakers, defibrillators (ICD's), other devices/implants contraindicated for MRI, glomerular filtration rate <30 ml/min, etc.).
• Pregnancy.
• Inability to give informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Delayed enhancement magnetic resonance imaging (DE-MRI)	The group will include 15 patients with OSA 5 with mild OSA 5 with moderate OSA 5 with severe OSA
Control group	Delayed enhancement magnetic resonance imaging (DE-MRI)	This group will include 5 patients with no OSA

Primary Outcome Measures

Name	Time	Method
Percentage of atrial fibrosis in the left atrium measured by DE-MRI	Baseline visit	DE-MRI purpose is to quantify the degree of atrial structural remodeling or fibrosis Left Atrial Volume Max on MRI measurement reflects atrial load to provide insight into atrial remodeling Left Atrial Volume Min on MRI is important for understanding atrial function, particularly its ability to contract and expel blood into left ventricle Left Atrial Volume Index on MRI is an indicator of left atrial enlargement compared to raw volume measurements Left Atrial Emptying Fraction on MRI is a measure of atrial contractile function. Higher LAEF indicates better atrial function, while lower values can signal impaired atrial mechanics Left Atrial Global Strain on MRI which is the percentage change in myocardial length along the long axis of the left atrium, is calculated using a formula averaging the individual longitudinal strain values from each segment of the myocardium, providing a comprehensive measure of myocardial deformation

Trial Locations

Locations (2)

East Jefferson General Hospital; 🇺🇸 New Orleans, Louisiana, United States

Tulane University Medical Center; 🇺🇸 New Orleans, Louisiana, United States