Investigating Atrial Fibrosis in Patients with Obstructive Sleep Apnea
Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study
This study is trying to see if people with obstructive sleep apnea are more likely to develop atrial fibrosis compared to those without the condition.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tulane University Academic / other |
| Locations | 3 sites (New Orleans, Louisiana and 2 other locations) |
| Trial ID | NCT04814420 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with mild to severe obstructive sleep apnea confirmed by polysomnography, as well as controls without OSA or atrial fibrillation.
Not a fit: Patients with significant comorbidities affecting cardiac health or those with a prior diagnosis of atrial fibrillation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of atrial fibrosis in patients with obstructive sleep apnea.
How similar studies have performed: While the relationship between OSA and atrial fibrosis is being explored, this specific approach using DE-MRI in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Orleans, Louisiana and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.