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

Recruiting

• Conditions: Atrial Fibrillation

• Registration Number: NCT04703166
• Lead Sponsor: Tulane University School of Medicine

Brief Summary

To evaluate the progression of atrial myopathy through wearable devices and cardiac imaging.

Detailed Description

The Tulane iPredict Prevent (TiPP) project aims to study the aging of the heart in a diverse patient population using wearable digital health devices with the help of Samsung and Boston Scientific.

The innovative project seeks to correlate aging of the heart with daily biometric data obtained from wearable digital health devices, using Samsung's Galaxy Watch. Participants' biometric data, which include heart rate, step count, sleep patterns, and more, along with ECG readings from Preventice (Boston Scientific) Body Guardian Mini, will inform a machine learning model, providing real-time risk assessment of cardiovascular events.

In addition to monitoring biometric data, participants will undergo advanced cardiac imaging (CMR) scans at baseline and one-year follow-up to evaluate markers of aging of the heart (atrial myopathy). These scans, paired with the continuous data from the wearable devices, will offer a detailed understanding of the progression of atrial myopathy over time.

The TiPP study's unique approach of leveraging digital health technology represents an exciting innovation in cardiovascular research. This study's findings are expected to revolutionize our understanding of heart aging and, more importantly, the prediction and prevention of heart diseases in diverse patient populations.

Moreover, the study outcomes will allow us to accurately assess the clinical relevance of daily biometric data, leading to improved and personalized care. The insights gathered will be pivotal in informing early preventive interventions, significantly improving patient outcomes and transforming how we approach cardiovascular diseases and arrhythmias.

The primary outcome of the study will be evaluating the progression of atrial myopathy based on CMR scans. Meanwhile, secondary outcomes will include the incidence of heart failure, stroke, hospitalization, arrhythmias, and mortality during the study period.

With the increasing prevalence of cardiovascular diseases globally, the TiPP study, with its novel use of technology and inclusive approach, stands at the forefront of heart disease research, potentially altering the course of cardiovascular treatment and management.

Study Timeline

• Study First Submitted: 2021-01-07
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-11
• Status Verified: 2025-04
• Study Start: 2025-04-08
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-17
• Primary Completion: 2027-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Participants must meet the following criteria to be enrolled in the trial:

• 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 Criteria

Participants will be excluded from enrollment if any of the following criteria are present:

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Atrial Myopathy Progression	Based 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.

Secondary Outcome Measures

Name	Time	Method
Death Incidence	Through study completion, up to 52 weeks	During the 6 month and the 9 month phone call visits, we will check for mortality.
Heart Failure Incidence	Through study completion, up to 52 weeks	During the 6 month and 9 month phone call visits, we will ask the participants if they have had any incidence of heart failure.
Cerebrovascular Incidence	Through study completion, up to 52 weeks	During the 6 month and the 9 month phone call visits, we will ask the participants if they have had any clinically relevant cerebrovascular events such as stroke and/or Transient Ischemic Attack (TIA).
Hospitalization Incidence	Through study completion, up to 52 weeks	During the 6 month and the 9 month phone call visits, we will ask the participants if they have had any cardiac related hospitalization.
Arrhythmias Incidence	Through study completion, up to 52 weeks	During the 6 month and the 9 month phone call visits, we will ask the participants if they have had any incidence of any cardiac arrhythmias.

Trial Locations

Locations (1)

Tulane University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States