The Weight Of Cardiovascular Disease
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 26-008806
About this study
The purpose of this study is to evaluate the impact of a cardiometabolic clinic on percent body weight loss, body mass index (BMI), and visceral adiposity distribution in obese adults with cardiovascular disease (CVD) at 6 months.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available