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Tulane iPredict, Prevent Study for Atrial Myopathy

This observational study, called Tulane iPredict, Prevent (TiPP), is looking at how a heart condition called atrial myopathy (changes in the heart's upper chambers) progresses over time. Researchers are using a Samsung Galaxy Watch Active2 to collect daily information like your heart rate, steps, sleep, and oxygen levels. They will also use a Preventice Body Guardian Mini for ECG readings. You may be able to join if you have atrial fibrillation and are 18-79 years old, or if you are 40-79 years old and have a moderate to high risk for cardiovascular disease. The study aims to understand how these wearable device measurements relate to changes in your heart, which will be checked with advanced heart scans (CMR scans) at the beginning and after one year. The goal is to better predict and prevent heart diseases.

Study design
This is an observational study planning to enroll 360 participants. It uses wearable devices and cardiac imaging to understand heart changes.
What's involved
You would wear a Samsung Galaxy Watch Active2 and a Preventice Body Guardian Mini. You would also have advanced cardiac imaging (CMR scans) at the start of the study and again after one year.
Compensation
Not stated in the trial record.
Follow-up
Participants will have a follow-up CMR scan at 12 months.

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NCT04703166

Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.

Recruiting
Not specifiedAges 18–79Observational
Tulane University School of Medicine
~360 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:Samsung Galaxy Watch Active2

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Atrial Myopathy Progression
Measured over Based on results from CMR scan at baseline at 12-Months CMR scan

Conditions

Atrial Fibrillation

Explore related trials

ArrhythmiaAtrial FibrillationAtrial MyopathyCardiovascular Disorder

Where it's being run

1 sites across 1 states
Louisiana1

Study leadership

  • Nassir F Marrouche, MD · PRINCIPAL_INVESTIGATOR · Tulane University School of Medicine

Who to contact

Quintrele Jones, MPH
[email protected]
504-988-3063
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participants with atrial fibrillation aged 18 to 79 years old, or
Participants aged 40 to 79 years old, at moderate or high risk for CVD as defined by the 10-year risk Atherosclerotic Cardiovascular Disease (ASCVD), a validated risk calculation tool.
Participants who have access to internet/e-mail in their homes.
Participants who have access to a compatible Android mobile device or compatible iOS mobile device (iPhone 4S or newer, iPad 3 or newer).
Participants who are able and willing to return to the study clinic one-year following their baseline CMR for a follow-up appointment and 12-month CMR.
Participants who are able to read, understand, and sign the consent form.

Exclusion

Any health-related gadolinium/MRI contraindications (e.g. allergy to gadolinium, pacemakers, Implantable Cardioverter Defibrillators (ICD's), other devices/implants contraindicated for use of MRI, etc.).
Participants weighing \>300 lbs. (MRI quality decreases as BMI increases).
Participants with renal insufficiency (Glomerular Filtration Rate (GFR) \<30 mL per minute per 1.73 m2) or acute/severe renal dysfunction/disease.
Women who are pregnant at the time of enrollment/consent. (Should a participant become pregnant during the course of the study, no CMR will be performed until 10 days, postpartum).
Participants who do not have access to the internet/e-mail.
Participants who do not have a compatible Android mobile device or compatible iOS mobile device (iPhone 4S or newer, iPad 3 or newer).
Participants with cognitive impairments affecting their ability to be compliant with wearing and maintaining wearable devices.
Participants who are unable or unwilling to return to the study clinic one-year post baseline for their follow-up appointment and CMR.
Participants with cognitive impairments who are unable to give informed consent.

What this trial measures

  • Atrial Myopathy ProgressionBased on results from CMR scan at baseline at 12-Months CMR scan

    To evaluate changes of atrial myopathy (via the extent of atrial fibrosis, the shape of left atrium \[LA\] and the function of the LA). This will be assessed via CMR scans.