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Atrial Fibrosis Progression in Sleep Apnea Patients: A Pilot Study

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ClinicalTrials.gov Identifier: NCT04814420
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
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 and progression of atrial fibrosis on Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) in OSA patients without atrial fibrillation (AF).

The investigators will also investigate the correlation between OSA metrics (nocturnal oxygen saturation and Apnea Hypopnea Index (AHI)) and degree of fibrosis at baseline and its progression.


Condition or disease Intervention/treatment Phase
Atrial Fibrillation Obstructive Sleep Apnea Device: Delayed enhancement magnetic resonance imaging (DE-MRI) Not Applicable

Detailed Description:

This is a prospective observational pilot study. Fifteen 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.

Patients will be followed over a period of 6 months with a wearable device (WATCHPAT 300) that will record a home sleep apnea study biweekly, including OSA metrics like AHI and nocturnal oxygen variations. Patients will also use an ElectroCardioGram (ECG) Check device for arrhythmia detection.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Twenty participants would be an adequate sample size for this pilot study to represent all stages of OSA and controls (5 mild, 5 moderate, 5 severe OSA, and 5 controls with no OSA).
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Atrial Fibrosis Progression in Sleep Apnea Patients: A Pilot Study
Actual Study Start Date : July 12, 2021
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: Experimental group
The group will include 15 patients with OSA 5 with mild OSA 5 with moderate OSA 5 with severe OSA
Device: Delayed enhancement magnetic resonance imaging (DE-MRI)
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.

Control group
This group will include 5 patients with no OSA
Device: Delayed enhancement magnetic resonance imaging (DE-MRI)
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.




Primary Outcome Measures :
  1. Percent change of atrial fibrosis measured by DE-MRI [ Time Frame: Baseline, 6 months ]
    The percent change will be measured via DE-MRI. The purpose of DE-MRI is to quantify the degree of atrial structural remodeling or fibrosis.


Secondary Outcome Measures :
  1. The occurrence of arrhythmia [ Time Frame: From baseline to 6 months ]
    The patients will use ECG check device to detect the arrhythmia occurrence.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Experimental group: (15 patients)

    • 18-75-year-old, AND
    • With mild to severe OSA (mild: Apnea Hypopnea Index: AHI between 5-15, Moderate AHI= 15-30, severe AHI>30), diagnosed by polysomnography.
    • Patient with a creatinine measurement within the last 6 months.
  • Control group (5 patients): patients with no lung or heart disease, matched by age and BMI.

Exclusion Criteria:

  • History of chronic heart failure (Left Ventricle Ejection fraction (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.).
  • BMI > 35 kg/m2 (affects DE-MRI quality).
  • Pregnancy.
  • Contraindications to WATCHPAT device (peripheral neuropathy).
  • Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the use of WATCHPAT).
  • Inability to give informed consent.
  • No access to proper smartphone technology and/or internet.
  • Inability to return to follow up visit.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04814420


Contacts
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Contact: Lilas Dagher, MD 504-208-7172 ldagher@tulane.edu
Contact: Agnieszka Jezierska-Drutel, PhD (504)988-6443 ajezierskadrutel@tulane.edu

Locations
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United States, Louisiana
Tulane University Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Lilas Dagher, MD    504-208-7172    ldagher@tulane.edu   
Contact: Agnieszka Jezierska-Drutel, PhD    (504)988-6443    ajezierskadrutel@tulane.edu   
Principal Investigator: Uzodinma Emerenini, MD         
Sub-Investigator: Lilas Dagher, MD         
Sponsors and Collaborators
Tulane University
Investigators
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Principal Investigator: Uzodinma Emerenini, MD Tulane University Medical Center
Publications:

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Responsible Party: Tulane University
ClinicalTrials.gov Identifier: NCT04814420    
Other Study ID Numbers: 2019-2081
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: July 14, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Tulane University:
Cardioversion
Ablation
Atrial Fibrosis
Delayed Enhancement Magnetic Resonance Imaging
Electrocardiogram
Nocturnal oxygen saturation
Apnea Hypopnea Index
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Atrial Fibrillation
Fibrosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases