NCT04703166

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

Tulane iPredict, Prevent (TiPP) Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 360 (estimated)
• Sponsor: Tulane University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	Samsung Galaxy Watch Active2	The Samsung wearable device will collect data; photoplethysmography (PPG) waveforms, heart rate, heart rate variability, step counts, oxygen saturation levels, sleep pattern and quality.

Timeline

• Start date: 2025-04-08
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2021-01-11
• Last updated: 2025-04-17

Locations

1 site across 1 country: United States