NCT06576050Completed
WeighT LOSS Surgery and Comprehensive Cardiometabolic Responses to to EXercise
A Prospective Evaluation of Subjects Undergoing Weight Loss Surgery to Determine Cardiometabolic Responses to Exercise
Source: ClinicalTrials.gov · Last updated 13 Aug 2026
Brief summary (registry, in English)
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 activity, including 6 minute walk distance, resting metabolic rate, the metabolic cost of initiating exercise, and low-level, intermediate, peak exercise, and recovery oxygen utilization patterns will be examined in relation to weight loss in people having bariatric surgery. The investigators also aim to learn more about the relationship between obesity, exercise intolerance, and heart failure with preserved ejection fraction (HFpEF). The investigators are interested in the extent to which HFpEF\'s manifestations are preventable or reversible with weight-loss interventions. The main questions it aims to answer are: 1. How does weight loss surgery affect comprehensive measures of physical activity? 2. What are the biochemical signatures of obesity and their reversibility in patients with HFpEF and obesity?
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 21 (actual)
- First submitted
- 26 Aug 2024
- Start date
- 25 Jan 2022
- Primary completion date
- 2 Aug 2024
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Heart failure, Obesity
- NCT number
- NCT06576050
What you commit to
- Study type: Observational
- Participants enrolled: 21
- From 25 Jan 2022 to the primary completion date, 2 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous Bariatric surgery
Other illness
- 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)
Lab values
- History of systolic heart failure, past or present LVEF of \<40%
Other
- Pregnancy
Who the study is looking for
- 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)
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.