Recruiting NCT06053645
The Weight of Cardiovascular Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiovascular Diseases, Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Weight of Cardiovascular Disease: A Prospective Pilot Study of Obese Adults With Cardiovascular Disease Evaluated in a Novel Cardiometabolic Clinic
Overview
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.
Primary outcome measures
- Percent body weight loss [Time frame: 12 months]
- Change in Body Mass Index (BMI) [Time frame: Baseline, 12 months]
- Change in visceral adiposity distribution [Time frame: Baseline, 12 months]
Secondary outcome measures (12)
- 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]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06053645 · 23-003696