The Weight of Cardiovascular Disease

Recruiting

• Conditions: Obesity; Cardiovascular Diseases

• Registration Number: NCT06053645
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-19
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-26
• Study Start: 2024-04-22
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percent body weight loss	12 months	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.
Change in Body Mass Index (BMI)	Baseline, 12 months	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
Change in visceral adiposity distribution	Baseline, 12 months	Change in visceral adiposity distribution measured using dual energy X-ray absorptiometry (DEXA).

Secondary Outcome Measures

Name	Time	Method
Change in Peak Tricuspid Regurgitation (TR) Velocity	Baseline, 12 months	Peak TR Velocity (m/s) will be measured using transthoracic echocardiography (TTE) to assess left ventricular diastolic function.
Change in point of care glucose	Baseline, 12 months	Change in estimated glucose value (mg/dl) obtained from point of care fingerstick testing.
Change in Blood Pressure	Baseline, 12 months	Measured in millimeters of mercury (mmHg)
Change in six-minute walk test	Baseline, 12 months	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.
Change in psychosocial distress as measured by the Weight Bias Internalization-Modified (WBIS-M) scale	Baseline, 12 months	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.
Change in quality of diet	Baseline, 12 months	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.
Change in psychosocial distress as measured by Screening Tool for Psychological Distress (STOP-D)	Baseline, 12 months	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.
Change in E/e'	Baseline, 12 months	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.
Change in Right Atrial (RA) Pressure	Baseline, 12 months	RA pressure (mm Hg) will be measured by transthoracic echocardiography (TTE) to assess left ventricular diastolic function.
Change in heart rate with detection of arrhythmia	Baseline, 12 months	Average number of arrhythmias identified by an Apple watch worn by subjects for the duration of the study.
Change in psychosocial distress as measured by Impact of Event Scale-Revised (IES-R)	Baseline, 12 months	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.
Change in psychosocial distress as measured by Adverse Childhood Experience (ACE) Questionnaire	Baseline, 12 months	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.
Change in functional aerobic capacity (VO2 Max)	Baseline, 12 months	VO2 Max is measured as milliliters of oxygen per kilogram of body weight per minute (ml/kg/min) during cardiopulmonary exercise test
Change in artificial intelligence electrocardiogram (AI-ECG) age	Baseline, 12 months	AI-ECG age is the subject's predicted age based on artificial intelligence analysis of electrocardiograms (ECGs).
Change in Left Atrial (LA) volume index	Baseline, 12 months	LA volume index (ml/m\^2) will be measured by transthoracic echocardiography (TTE) to assess left ventricular diastolic function.
Change in physical activity	Baseline, 12 months	Average number of steps a subject takes daily as collected by an Apple watch worn by subjects for the duration of the study.
Change in cardio fitness	Baseline, 12 months	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.

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States