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Cardiovascular DiseasesNCT06053645

The Weight of Cardiovascular Disease

An observational study of Cardiovascular Diseases and Obesity, run by Mayo Clinic at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiovascular Diseases, Obesity
How many people
31 participants
Where
1 siteUnited States
Study dates
22 Apr 2024to May 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients referred to the cardiometabolic clinic at Mayo Clinic Hospital in Rochester, MN will be recruited for participation.

Who may be able to join

  • 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

Who cannot join

  • BMI <30 kg/m2
  • Pregnancy or lactating women
  • Hemodynamically unstable CVD
  • Active malignancy
  • Autoimmune or systemic inflammatory diseases
  • Severe renal or hepatic failure
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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.

Medical subject headings
Cardiovascular Diseases, Obesity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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

    Measured: Baseline, 12 months

  3. Change in visceral adiposity distribution

    Change in visceral adiposity distribution measured using dual energy X-ray absorptiometry (DEXA).

    Measured: Baseline, 12 months

Secondary outcomes (17)
  1. Change in Blood Pressure

    Measured in millimeters of mercury (mmHg)

    Measured: Baseline, 12 months

  2. Change in point of care glucose

    Change in estimated glucose value (mg/dl) obtained from point of care fingerstick testing.

    Measured: Baseline, 12 months

  3. 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.

    Measured: Baseline, 12 months

  4. 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.

    Measured: Baseline, 12 months

  5. 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.

    Measured: Baseline, 12 months

  6. 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.

    Measured: Baseline, 12 months

  7. 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

    Measured: Baseline, 12 months

  8. 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).

    Measured: Baseline, 12 months

  9. 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.

    Measured: Baseline, 12 months

  10. 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.

    Measured: Baseline, 12 months

  11. Change in Right Atrial (RA) Pressure

    RA pressure (mm Hg) will be measured by transthoracic echocardiography (TTE) to assess left ventricular diastolic function.

    Measured: Baseline, 12 months

  12. 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.

    Measured: Baseline, 12 months

  13. 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.

    Measured: Baseline, 12 months

  14. 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.

    Measured: Baseline, 12 months

  15. 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.

    Measured: Baseline, 12 months

  16. 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.

    Measured: Baseline, 12 months

  17. 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.

    Measured: Baseline, 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2023
  2. Study start22 Apr 2024
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06053645
Sponsor's protocol ID
26-008806
Status last verified
Sep 2026
First submitted
19 Sep 2023
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiovascular Diseases and Obesity, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent body weight loss (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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