Clinical trial NCT06053645: The Weight of Cardiovascular Disease
Official title: The Weight of Cardiovascular Disease: A Prospective Pilot Study of Obese Adults With Cardiovascular Disease Evaluated in a Novel Cardiometabolic Clinic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-09-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred to the cardiometabolic clinic at Mayo Clinic Hospital in Rochester, MN will be recruited for participation.

Brief summary: 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 12 months.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percent body weight loss
timeFrame: 12 months
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, 12 months
measure: Change in visceral adiposity distribution
timeFrame: Baseline, 12 months
Secondary outcomes:
measure: Change in Blood Pressure
timeFrame: Baseline, 12 months
measure: Change in point of care glucose
timeFrame: Baseline, 12 months
measure: Change in quality of diet
timeFrame: Baseline, 12 months
measure: Change in psychosocial distress as measured by Screening Tool for Psychological Distress (STOP-D)
timeFrame: Baseline, 12 months
measure: Change in psychosocial distress as measured by Impact of Event Scale-Revised (IES-R)
timeFrame: Baseline, 12 months
measure: Change in psychosocial distress as measured by Adverse Childhood Experience (ACE) Questionnaire
timeFrame: Baseline, 12 months
measure: Change in functional aerobic capacity (VO2 Max)
timeFrame: Baseline, 12 months
measure: Change in artificial intelligence electrocardiogram (AI-ECG) age
timeFrame: Baseline, 12 months
measure: Change in E/e'
timeFrame: Baseline, 12 months
measure: Change in Peak Tricuspid Regurgitation (TR) Velocity
timeFrame: Baseline, 12 months
measure: Change in Right Atrial (RA) Pressure
timeFrame: Baseline, 12 months
measure: Change in Left Atrial (LA) volume index
timeFrame: Baseline, 12 months
measure: Change in physical activity
timeFrame: Baseline, 12 months
measure: Change in heart rate with detection of arrhythmia
timeFrame: Baseline, 12 months
measure: Change in cardio fitness
timeFrame: Baseline, 12 months
measure: Change in six-minute walk test
timeFrame: Baseline, 12 months
measure: Change in psychosocial distress as measured by the Weight Bias Internalization-Modified (WBIS-M) scale
timeFrame: Baseline, 12 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Kyla Lara-Breitinger, M.D.
role: PRINCIPAL_INVESTIGATOR
References: