Status:
ACTIVE_NOT_RECRUITING
WeighT LOSS Surgery and Comprehensive Cardiometabolic Responses to to EXercise
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Amgen
Conditions:
Heart Failure
Obesity
Eligibility:
All Genders
40+ years
Brief Summary
The goal of this study is to define how treatment of obesity impacts cardiometabolic performance during exercise in patients with established HFpEF or at risk for HFpEF. Multi-dimensional physical act...
Detailed Description
A prospective evaluation of subjects with HFpEF or at risk for HFpEF undergoing laparoscopic sleeve gastrectomy surgery to determine cardiometabolic responses to exercise. The investigators will pros...
Eligibility Criteria
Inclusion
- Patients scheduled for weight loss surgery (gastric sleeve procedure)
- 40 years or older
- PMH one or more of the following:
- Diabetes Mellitus
- Hypertension requiring medical treatment
- Age \>65 years
- History of HFpEF
- Echocardiographic findings: left atrial enlargement (LAE), left ventricular hypertrophy (LVH), or right ventricular systolic pressure \>40 mmHg (RVSP)
Exclusion
- 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)
Key Trial Info
Start Date :
January 25 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06576050
Start Date
January 25 2022
End Date
November 1 2024
Last Update
September 4 2024
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114