Clinical trial NCT04703166: Tulane iPredict, Prevent Study to Evaluate the Progression of Atrial Myopathy.
Official title: Tulane iPredict, Prevent (TiPP) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Atrial Myopathy
Cardiovascular Risk Factors
Heart Murmurs
Arrhythmias
Cardiac Disease
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Samsung
name: Preventice
First posted: 2021-01-11
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 360 participants, male or female with atrial fibrillation (18-79 years) or have moderate to high risk factors (40-79 years) for atherosclerotic cardiovascular disease as verified by the ASCVD risk estimator.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Atrial Myopathy Progression
timeFrame: Based on results from CMR scan at baseline at 12-Months CMR scan
Secondary outcomes:
measure: Heart Failure Incidence
timeFrame: Through study completion, up to 52 weeks
measure: Cerebrovascular Incidence
timeFrame: Through study completion, up to 52 weeks
measure: Hospitalization Incidence
timeFrame: Through study completion, up to 52 weeks
measure: Arrhythmias Incidence
timeFrame: Through study completion, up to 52 weeks
measure: Death Incidence
timeFrame: Through study completion, up to 52 weeks
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University School of Medicine
state: Louisiana
Study officials:
affiliation: Tulane University School of Medicine
name: Nassir F Marrouche, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Bieging ET, Morris A, Wilson BD, McGann CJ, Marrouche NF, Cates J. Left atrial shape predicts recurrence after atrial fibrillation catheter ablation. J Cardiovasc Electrophysiol. 2018 Jul;29(7):966-972. doi: 10.1111/jce.13641. Epub 2018 Jun 19.
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citation: Siebermair J, Suksaranjit P, McGann CJ, Peterson KA, Kheirkhahan M, Baher AA, Damal K, Wakili R, Marrouche NF, Wilson BD. Atrial fibrosis in non-atrial fibrillation individuals and prediction of atrial fibrillation by use of late gadolinium enhancement magnetic resonance imaging. J Cardiovasc Electrophysiol. 2019 Apr;30(4):550-556. doi: 10.1111/jce.13846. Epub 2019 Jan 24.
citation: Perez MV, Mahaffey KW, Hedlin H, Rumsfeld JS, Garcia A, Ferris T, Balasubramanian V, Russo AM, Rajmane A, Cheung L, Hung G, Lee J, Kowey P, Talati N, Nag D, Gummidipundi SE, Beatty A, Hills MT, Desai S, Granger CB, Desai M, Turakhia MP; Apple Heart Study Investigators. Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation. N Engl J Med. 2019 Nov 14;381(20):1909-1917. doi: 10.1056/NEJMoa1901183.
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