Health TrialsbyHealthPanel

Atrial Fibrosis in Obstructive Sleep Apnea Patients: A Pilot Study

ConditionsAtrial FibrillationObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTulane University

About this trial

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).

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Delayed enhancement magnetic resonance imaging (DE-MRI)

    Device

    The patient will be injected with late gadolinium enhancement (0.01 mmol/kg standard dosage), which is a contrast agent used in clinical practice in MRI imaging studies. The contrast agent is used to enhance specific regions/tissues on MRI and, in this study, will allow the investigators to identify fibrotic tissue within the heart. The patient then undergoes the MRI sequence, which lasts approximately 20-25 minutes. Images will be reviewed for quality by trained technicians. This will be repeated after 6 months.

Treatment groups

60 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CExperimental treatment 1 intervention
Group D: Group DExperimental treatment 1 intervention
Group E: Group EExperimental treatment 1 intervention
Group F: Group FOther 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of atrial fibrosis in the left atrium measured by DE-MRI

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

Time frame
Baseline visit

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tulane University

Lead sponsor

Source ClinicalTrials.gov
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