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.
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
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.
- Conditions
- Cardiovascular Diseases, Obesity
- Medical subject headings
- Cardiovascular Diseases, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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)
Change in Blood Pressure
Measured in millimeters of mercury (mmHg)
Measured: Baseline, 12 months
Change in point of care glucose
Change in estimated glucose value (mg/dl) obtained from point of care fingerstick testing.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
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.
- First posted26 Sep 2023
- Study start22 Apr 2024
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyla M. Lara-Breitinger, Mayo Clinic
- Investigators
- Kyla Lara-Breitinger, M.D., Principal investigator, Mayo Clinic
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Weight of Cardiovascular Disease: A Prospective Pilot Study of Obese Adults With Cardiovascular Disease Evaluated in a Novel Cardiometabolic Clinic
- ClinicalTrials.gov ID
- NCT06053645
- Acronym / sponsor ID
- 26-008806
- Conditions
- Cardiovascular Diseases, Obesity
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 26 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the cardiometabolic clinic at Mayo Clinic Hospital in Rochester, MN will be recruited for participation.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- BMI <30 kg/m2
- Pregnancy or lactating women
- Hemodynamically unstable CVD
- Active malignancy
- Autoimmune or systemic inflammatory diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percent body weight loss
Time frame: 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)
Time frame: 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
Time frame: Baseline, 12 months
Change in visceral adiposity distribution measured using dual energy X-ray absorptiometry (DEXA).
17 secondary outcomes
Change in Blood Pressure
Time frame: Baseline, 12 months
Change in point of care glucose
Time frame: Baseline, 12 months
Change in quality of diet
Time frame: Baseline, 12 months
Change in psychosocial distress as measured by Screening Tool for Psychological Distress (STOP-D)
Time frame: Baseline, 12 months
Change in psychosocial distress as measured by Impact of Event Scale-Revised (IES-R)
Time frame: Baseline, 12 months
Change in psychosocial distress as measured by Adverse Childhood Experience (ACE) Questionnaire
Time frame: Baseline, 12 months
Change in functional aerobic capacity (VO2 Max)
Time frame: Baseline, 12 months
Change in artificial intelligence electrocardiogram (AI-ECG) age
Time frame: Baseline, 12 months
Change in E/e'
Time frame: Baseline, 12 months
Change in Peak Tricuspid Regurgitation (TR) Velocity
Time frame: Baseline, 12 months
Change in Right Atrial (RA) Pressure
Time frame: Baseline, 12 months
Change in Left Atrial (LA) volume index
Time frame: Baseline, 12 months
Change in physical activity
Time frame: Baseline, 12 months
Change in heart rate with detection of arrhythmia
Time frame: Baseline, 12 months
Change in cardio fitness
Time frame: Baseline, 12 months
Change in six-minute walk test
Time frame: Baseline, 12 months
Change in psychosocial distress as measured by the Weight Bias Internalization-Modified (WBIS-M) scale
Time frame: Baseline, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyla Lara-Breitinger, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
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.