Obesity Treatment Outcomes in Cardiac Transplantation Patients
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 22-009063
About this study
The purpose of this study is to prospectively evaluate the safety and effectivenes of standard of care, individualized, comprehensive weight loss interventions in carefully selected patients with obesity undergoing cardiac transplant evaluation, including utilization of best lifestyle modifications and guidance to promote a healthy weight, possible medical therapy using FDA-approved weight loss medications and EBMTs with or without concomitant medical therapy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- BMI 35-40 kg/m^2.
- BMI 30-35kg/m^2 with diabetes or metabolic syndrome.
- NYHA Class II or higher heart failure.
- Age ≥ 18 and age ≤ 70 years.
Exclusion Criteria:
- Multiorgan transplant.
- Previous organ transplant.
- Previous history of gastric surgery.
- Chronic persistent nausea/vomiting.
- Delayed gastric emptying.
- Refractory GERD.
- Active Peptic Ulcer Disease.
- Hiatal Hernia > 3 cm.
- Concurrent opportunistic infections.
- Pregnancy.
- Gastrointestinal bleeding refractory to medical/endoscopic treatment.
Eligibility last updated 10/18/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Rahul Pannala, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available