An observational study in Heart Failure, Obesity and Weight Loss, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by Massachusetts General Hospital · Observational
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:
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 prospectively evaluate twenty-one patients to determine cardiometabolic responses to exercise before and 12-months after bariatric surgery. The investigators will map pulmonary/pulmonary vascular function, ventilatory efficiency (VE/VCO2 slope); left ventricular-systemic vascular function (based on echo measures) as well as exercise blood pressure responses (SBP at 30 Watts); sympathetic nervous system function during exercise will be assessed by heart rate-O2 pulse relationships; peripheral abnormalities characteristic of HFpEF will be measured by assessment of O2 kinetics during exercise onset and recovery. Additionally, global metabolic reserve will be captured by assessment of peak VO2. The comprehensive evaluation of these patients pre- and post-weight loss will further elucidate relationships between HFpEF and obesity, and their plasticity in response to weight loss, while also setting the stage to evaluate clinical trial endpoints that influence how patients function and feel (e.g. CPET-derived exercise capacity). The investigators will also assess exercise capacity and additional markers of metabolic health.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's enrollment of 21 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
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Subjects undergoing gastric sleeve bypass weight loss procedure
PMH one or more of the following:
Exclusion Criteria:
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).
Each subject will undergo laparoscopic sleeve gastrectomy, as part of their clinical care. This is a single-arm study, in which the investigators collect data prior to the procedure, 3 months after the procedure, and 12 months after the procedure.
Change in Peak VO2
To precisely quantify changes in peak oxygen uptake (peak VO2) achieved pre and post gastric sleeve surgery by performing cardiopulmonary exercise testing (CPET) at baseline (pre-surgery) and 12-months post-procedure (+/- 3 months). CPETs will be performed on a cycle ergometer.
Time frame: baseline to month 12
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Massachusetts General Hospital