NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

WeighT LOSS Surgery and Comprehensive Cardiometabolic Responses to to EXercise

CompletedN/A

Sponsor: Massachusetts General Hospital

Conditions: Heart Failure, Obesity, Weight Loss, Heart Failure With Preserved Ejection Fraction

Countries: United States

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?

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

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)

Locations (1)

Boston, Massachusetts, United States