Investigating Atrial Fibrosis in Patients with Obstructive Sleep Apnea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to explore the relationship between obstructive sleep apnea (OSA) and the development of atrial fibrosis. It will involve 60 patients with varying degrees of OSA and 5 control subjects, all of whom will undergo delayed enhancement magnetic resonance imaging (DE-MRI) to assess the presence of atrial fibrosis. The study will collect demographic data, medical history, and previous polysomnography results to confirm OSA diagnoses. The goal is to determine if OSA is an independent risk factor for atrial fibrosis in patients without a history of atrial fibrillation.

Why it matters

Who can join: the full rules

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.

Where it's running

• East Jefferson General Hospital
  New Orleans, Louisiana, United States Recruiting
• University Medical Center
  New Orleans, Louisiana, United States Recruiting
• Tulane Doctors - Speciality Care - Napoleon
  New Orleans, Louisiana, United States Recruiting

Study contacts

• Principal investigator: Amitabh Pandey, MD — Tulane University School of Medicine
• Study coordinator: Christian Massad, MD
• Email: cmassad@tulane.edu
• Phone: 504-988-3072

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.