Bariatric Surgery & Heart Failure Study

Condition/Intervention: Heart Failure

Eligibility

Key Inclusion Criteria

  • 18 years of age or older
  • Ambulatory outpatients with advanced heart failure in NYHA classes II-IV, including patients with ventricular assist devices, that are referred for bariatric surgery
  • Stable medical regimen (except for adjustment in diuretic dosing) for the past month
  • Body mass index ≥ 35 kg/m2
  • Ejection fraction ≤ 40% assessed within the past 6 months

Key Exclusion Criteria

  • Presence of severe life-shortening co-morbidities or life expectancy < 1 year
  • Inability to give informed consent
  • Currently listed for heart transplant
  • Currently requiring inotrope support at home
  • Hospitalization within the past month
  • Age above 65 years
  • Uncontrolled psychiatric illness (such as uncontrolled depression)
  • Recent myocardial infarction or ventricular tachycardia/fibrillation requiring ICD defibrillation (within last three months)
  • Other non-cardiac illnesses leading to high-risk operative candidacy such as severe COPD or severe renal insufficiency

Full Study Name

Observational Review of Clinical Outcomes in Heart Failure Patients Undergoing Bariatric Surgery (IRB no. 29045)

Summary

The purpose of this study is to collect information to learn more about outcomes in heart failure patients undergoing bariatric surgery. Participants will be asked to complete a questionnaire. Researchers will use this information to confirm that bariatric surgery, a surgery for weight loss, is safe and effective in patients with heart failure.


Principal Investigator

Michele Hamilton, MD

Co-Investigators

Jon Kobashigawa, MD
Jignesh Patel, MD, PhD
Michelle Kittleson, MD, PhD

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