Clinical Trials

Inclusion Criteria:

• Age ≥ 18 years

• BMI ≥30 kg/m2

• At least one of the following CVD: atrial fibrillation (AF), coronary artery disease (CAD), HFpEF (heart failure with preserved ejection fraction), HFrEF (heart failure with reduced ejection fraction), ACHD (adult congenital heart disease), or valvular heart disease

• Patients evaluated in the Cardiometabolic clinic

• Willingness to complete questionnaires/surveys

• Ability to complete monthly self-assessments at home

• The ability to complete bi-weekly Apple Watch ECG recordings is optional and not required for participation in the study. The ECG data is stored in a Microsoft SQL database. All Epic users can see the Apple watch data in AI ECG Dashboard application, however any output is labeled as “research” and no interpretation should be applied to Apple Watch ECGs. The raw ECG data is on a secure file share with limited access to only authorized researchers. The study is using the AI ECG Dashboard solely for the display of results from the AI ECG at baseline and at one year (Completion of the study).

• Optional Apple watch ECG data will be obtained in all study participants as the means to pull the Health Kit data, however, only study participants 22 years and older will have their Apple ECG analyzed.

Exclusion Criteria:

• Age <18 years

• BMI <30 kg/m2

• Pregnancy or lactating women

• Hemodynamically unstable CVD

• Active malignancy

• Autoimmune or systemic inflammatory diseases

• Severe renal or hepatic failure

• Being considered unsafe to participate as determined by the study physician

• Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic medications, or other medications as determined by the study NP or physician

• Patients with active psychosis, mania, or substance use disorders

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 08/03/2026. Questions regarding updates should be directed to the study team contact.