Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT06576050
Eligibility Criteria:
Inclusion Criteria:
* Patients scheduled for weight loss surgery (gastric sleeve procedure)
* 40 years or older
* PMH one or more of the following:
1. Diabetes Mellitus
2. Hypertension requiring medical treatment
3. Age \>65 years
4. History of HFpEF
5. Echocardiographic findings: left atrial enlargement (LAE), left ventricular hypertrophy (LVH), or right ventricular systolic pressure \>40 mmHg (RVSP)
Exclusion Criteria:
* Previous Bariatric surgery
* Pregnancy
* History of systolic heart failure, past or present LVEF of \<40%
* Inability to perform exercise testing on a cycle ergometer (i.e. orthopedic conditions that preclude cycling or walking, recent systemic illness that compromises exercise capacity).
* Any contraindication to performing exercise testing or any history of ventricular arrhythmia, any recent (within the last 3 months) or untreated supraventricular arrhythmia, elevated blood pressure at the time of presentation for exercise testing (\>155 mmHg systolic, or \>95 mmHg diastolic blood pressure), active or recent exacerbation of congestive heart failure, or history of reactive airways disease that is induced by exercise).
* Acute myocardial infarction (3-5 days) or unstable angina
* Uncontrolled symptomatic arrhythmias
* Active endocarditis
* Acute myocarditis or pericarditis
* Symptomatic severe aortic stenosis
* Acute pulmonary embolism or DVT
* Suspected dissecting aneurysm
* Uncontrolled asthma
* Room air desaturation to \<85%
* Acute non-cardiopulmonary disorder that may affect exercise performance (infection, orthopedic problem)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT06576050
Study Brief:
Protocol Section:
NCT06576050