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DE-MRI for Sleep Apnea-Related Heart Changes

N/A
Recruiting
Led By Amitabh Pandey, MD
Research Sponsored by Tulane University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Experimental group: 18-75-year-old with mild to severe OSA diagnosed by polysomnography
Control group: Patients with no lung or heart disease, matched by age and BMI
Must not have
Inability to give informed consent
Other advanced pulmonary disease (severe Chronic Obstructive Pulmonary Disease (COPD) or asthma, pulmonary hypertension) or central sleep apnea
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trialis researching if sleep apnea can cause changes to the heart and how those changes are related to oxygen levels and the severity of sleep apnea.

Who is the study for?
This study is for adults aged 18-75 with mild to severe Obstructive Sleep Apnea (OSA) diagnosed by sleep studies, who have normal kidney function. It excludes those with serious heart conditions, other advanced lung diseases, contraindications to MRI scans like allergies or certain implants, pregnant women, and individuals unable to consent or follow up.
What is being tested?
The trial aims to detect atrial fibrosis progression in OSA patients using Delayed Enhancement Magnetic Resonance Imaging (DE-MRI). It will also explore the relationship between OSA severity and fibrosis. Participants are divided into two groups: one with OSA and another healthy control group matched by age and BMI.
What are the potential side effects?
There may be minimal side effects related to DE-MRI such as discomfort from lying still during the scan or a rare allergic reaction to the contrast dye used in imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old and have been diagnosed with OSA through a sleep study.
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I have no lung or heart disease and match the age and BMI criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to understand or sign the consent form.
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I have severe lung problems or sleep apnea.
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I have a history of heart issues, including heart failure or a heart attack.
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I cannot have an MRI due to allergies, devices like pacemakers, or poor kidney function.
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I have had heart or chest surgery before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent change of atrial fibrosis measured by DE-MRI
Secondary study objectives
The occurrence of arrhythmia

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Experimental groupExperimental Treatment1 Intervention
The group will include 15 patients with OSA 5 with mild OSA 5 with moderate OSA 5 with severe OSA
Group II: Control groupExperimental Treatment1 Intervention
This group will include 5 patients with no OSA

Find a Location

Who is running the clinical trial?

Tulane UniversityLead Sponsor
123 Previous Clinical Trials
239,440 Total Patients Enrolled
5 Trials studying Atrial Fibrillation
1,062 Patients Enrolled for Atrial Fibrillation
Amitabh Pandey, MDPrincipal InvestigatorTulane University Medical Center
Uzodinma Emerenini, MDPrincipal InvestigatorTulane University Medical Center
Nassir Marrouche, MDStudy DirectorTulane University Medical Center
6 Previous Clinical Trials
1,048 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
648 Patients Enrolled for Atrial Fibrillation

Media Library

Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) Clinical Trial Eligibility Overview. Trial Name: NCT04814420 — N/A
Atrial Fibrillation Research Study Groups: Experimental group, Control group
Atrial Fibrillation Clinical Trial 2023: Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) Highlights & Side Effects. Trial Name: NCT04814420 — N/A
Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04814420 — N/A
~4 spots leftby Dec 2025
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