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Atrial Fibrosis Progression in Sleep Apnea Patients: A Pilot Study

Primary Purpose

Atrial Fibrillation, Obstructive Sleep Apnea

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Delayed enhancement magnetic resonance imaging (DE-MRI)

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Cardioversion, Ablation, Atrial Fibrosis, Delayed Enhancement Magnetic Resonance Imaging, Electrocardiogram, Nocturnal oxygen saturation, Apnea Hypopnea Index

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Tulane University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control group

Arm Description

The group will include 15 patients with OSA 5 with mild OSA 5 with moderate OSA 5 with severe OSA

This group will include 5 patients with no OSA

Outcomes

Primary Outcome Measures

Percent change of atrial fibrosis measured by DE-MRI

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

The occurrence of arrhythmia

The patients will use ECG check device to detect the arrhythmia occurrence.

Full Information

NCT ID

NCT04814420

First Posted

March 22, 2021

Last Updated

November 21, 2022

Sponsor

Tulane University

1. Study Identification

Unique Protocol Identification Number

NCT04814420

Brief Title

Atrial Fibrosis Progression in Sleep Apnea Patients: A Pilot Study

Official Title

Atrial Fibrosis Progression in Sleep Apnea Patients: A Pilot Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 12, 2021 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tulane University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Obstructive Sleep Apnea

Keywords

Cardioversion, Ablation, Atrial Fibrosis, Delayed Enhancement Magnetic Resonance Imaging, Electrocardiogram, Nocturnal oxygen saturation, Apnea Hypopnea Index

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Experimental

Arm Description

The group will include 15 patients with OSA 5 with mild OSA 5 with moderate OSA 5 with severe OSA

Arm Title

Control group

Arm Type

Other

Arm Description

This group will include 5 patients with no OSA

Intervention Type

Device

Intervention Name(s)

Delayed enhancement magnetic resonance imaging (DE-MRI)

Intervention Description

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 Measure Information:

Title

Percent change of atrial fibrosis measured by DE-MRI

Description

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.

Time Frame

Baseline, 6 months

Secondary Outcome Measure Information:

Title

The occurrence of arrhythmia

Description

The patients will use ECG check device to detect the arrhythmia occurrence.

Time Frame

From baseline to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Noor Makan, BS

Phone

504-988-3065

nmakan@tulane.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Quintrele Jones, MPH

Phone

504-988-3063

qjones1@tulane.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nassir Marrouche, MD

Organizational Affiliation

Tulane University Medical Center

Official's Role

Study Director

Facility Information:

Facility Name

Tulane University Medical Center

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Noor Makan, MD

Phone

504-988-3065

nmakan@tulane.edu

First Name & Middle Initial & Last Name & Degree

Quintrele Jones, MPH

Phone

504-988-3063

qjones1@tulane.edu

First Name & Middle Initial & Last Name & Degree

Nassir Marrouche, MD

First Name & Middle Initial & Last Name & Degree

Lilas Dagher, MD

12. IPD Sharing Statement

Citations:

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Atrial Fibrosis Progression in Sleep Apnea Patients: A Pilot Study

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