The Weight of Cardiovascular Disease

The Weight of Cardiovascular Disease: A Prospective Pilot Study of Obese Adults With Cardiovascular Disease Evaluated in a Novel Cardiometabolic Clinic

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Obesity

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Preventive/Vascular Research Team; Phone Number: (507) 538-7425; Email: RSTCVRUPREVENT@mayo.edu
• Study Contact Backup: Name: Kyla Lara-Breitinger, M.D.; Phone Number: (507) 284-4441; Email: Lara.Kyla@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic in Rochester
      • Contact: Preventive/Vascular Research Team; Phone Number: (507) 538-7425; Email: RSTCVRUPREVENT@mayo.edu
      • Contact: Kyla Lara-Breitinger, M.D.; Phone Number: (507) 284-4441; Email: Lara.Kyla@mayo.edu
      • Principal Investigator: Kyla Lara-Breitinger, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent body weight loss	Total percent body weight loss will be reported at 12 months based on the following formula: (Starting baseline weight minus current weight) / (starting baseline weight) x 100 equals % of body weight loss.	12 months
Change in Body Mass Index (BMI)	Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703	Baseline, 12 months
Change in visceral adiposity distribution	Change in visceral adiposity distribution measured using dual energy X-ray absorptiometry (DEXA).	Baseline, 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Blood Pressure	Measured in millimeters of mercury (mmHg)	Baseline, 12 months
Change in point of care glucose	Change in estimated glucose value (mg/dl) obtained from point of care fingerstick testing.	Baseline, 12 months
Change in quality of diet	Change in quality of diet will be assessed by the Mini-EAT (Eating Assessment Tool). The Mini-EAT is a 9 item questionnaire that asks subjects how often they eat different types of foods (e.g. fruits, vegetables, legumes, etc.). Subjects respond on a scale of "I do not eat it at all" to "6 or more servings per day." Higher scores on the Mini-EAT represent a better quality of diet.	Baseline, 12 months
Change in psychosocial distress as measured by Screening Tool for Psychological Distress (STOP-D)	Psychosocial distress will be measured by the STOP-D survey. The STOP-D survey asks subjects to rate how often over the last 2 weeks they have felt depressed, anxious, stressed, angry, or lacking social support on a scale of 0-Not at all to 9-Severely. Each item is scored separately without a summed score for overall distress. Higher individual scores on the STOP-D items represent worse psychosocial distress.	Baseline, 12 months
Change in psychosocial distress as measured by Impact of Event Scale-Revised (IES-R)	Psychosocial distress will be measured by the IES-R. The IES-R is a questionnaire which asks subjects to rate how distressed or bothered during the past seven days they have been by difficulties that people sometimes have after stressful life events. Responses can range from 0-Not at all to 4-Extremely. Items on the questionnaire are grouped into 3 subscales: Intrusion, Avoidance, and Hyperarousal with scores on each subscale being the mean item response of all items in that group, thus scores for each subscale also range from 0 to 4. Higher scores are indicative of more psychosocial distress following the specific life event of focus.	Baseline, 12 months
Change in psychosocial distress as measured by Adverse Childhood Experience (ACE) Questionnaire	Psychosocial distress will be measured by the ACE Questionnaire. The ACE Questionnaire asks subjects various questions regarding life experiences from the first 18 years of life that may be considered adverse experiences (e.g. parental abuse, neglect, parental divorce, etc.). Subjects answer each question with a yes or no selection. The more questions answered yes represents worse psychosocial distress.	Baseline, 12 months
Change in functional aerobic capacity (VO2 Max)	VO2 Max is measured as milliliters of oxygen per kilogram of body weight per minute (ml/kg/min) during cardiopulmonary exercise test	Baseline, 12 months
Change in artificial intelligence electrocardiogram (AI-ECG) age	AI-ECG age is the subject's predicted age based on artificial intelligence analysis of electrocardiograms (ECGs).	Baseline, 12 months
Change in E/e'	E/e' will be measured using transthoracic echocardiography (TTE). It is defined as the ratio of peak early diastolic mitral inflow velocity (E) and peak early diastolic mitral annular velocity (e') and will be used to assess left ventricular diastolic function.	Baseline, 12 months
Change in Peak Tricuspid Regurgitation (TR) Velocity	Peak TR Velocity (m/s) will be measured using transthoracic echocardiography (TTE) to assess left ventricular diastolic function.	Baseline, 12 months
Change in Right Atrial (RA) Pressure	RA pressure (mm Hg) will be measured by transthoracic echocardiography (TTE) to assess left ventricular diastolic function.	Baseline, 12 months
Change in Left Atrial (LA) volume index	LA volume index (ml/m^2) will be measured by transthoracic echocardiography (TTE) to assess left ventricular diastolic function.	Baseline, 12 months
Change in physical activity	Average number of steps a subject takes daily as collected by an Apple watch worn by subjects for the duration of the study.	Baseline, 12 months
Change in heart rate with detection of arrhythmia	Average number of arrhythmias identified by an Apple watch worn by subjects for the duration of the study.	Baseline, 12 months
Change in cardio fitness	Fitness level reported as high/above average/below average/low as collected by an Apple watch worn by subjects for the duration of the study.	Baseline, 12 months
Change in six-minute walk test	Measurement (meters) of distance a person can walk on flat ground in 6 minutes collected by an Apple watch worn by subjects for the duration of the study.	Baseline, 12 months
Change in psychosocial distress as measured by the Weight Bias Internalization-Modified (WBIS-M) scale	The WBIS-M is a 11-item instrument for measuring the extent to which overweight individuals think of themselves in terms of prevalent negative stereotypes about overweight and overweight individuals. Respondents can express their level of agreement on a 7-point Likert scale ranging from 'strongly disagree' (1) to 'strongly agree' (7). Items 1 and 9 need to be scored reversely. Scores are averaged to create a composite score and higher scores represent greater psychosocial distress.	Baseline, 12 months

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Kyla Lara-Breitinger, M.D., Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Estimated): October 20, 2025
• Last Update Submitted That Met QC Criteria: October 16, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Cardiovascular Diseases
• Other Study ID Numbers: 23-003696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No