Safety Study of Octreotide Injection to Prevent GI Bleeding in Patients With Left Ventricular Assist Device (LVAD)
Condition: Gastrointestinal Bleeding
MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage
Intervention: Octreotide LAR Depot
Intervention description: The subject will be seen in clinic every 4 weeks (+/- 4 days) through week 24. During weeks 25-36 the subject will receive a telephone call every 4 weeks +/- 4 days, from the research nurse to assess for changes occurring after the study drug was stopped. Subjects will receive a physical exam and interview at each visit to assess for any sign of GI bleeding at home as per standard protocol for HeartMate II patients and for potential drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study.
Intervention MeSH terms: Octreotide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GI Bleeding; Gastrointestinal bleeding; LVAD

Summary:

      The investigators hypothesize that octreotide LAR (Long Acting Release) safely decreases GI
      bleeding in patients with a left ventricular assist device (LVAD). Patients undergoing
      implantation of non-pulsatile, continuous-flow LVAD have a higher incidence of
      gastrointestinal bleeding. This is a significantly associated morbidity and can threaten a
      patient's life as well as their ability to undergo eventual heart transplantation secondary
      to both general health/strength and the potential development of antibodies to blood products
      that would make future transfusions and transplantations more difficult.

      If this research finds that use of octreotide LAR can decrease the incidence of
      gastrointestinal bleeding in this patient population, it will revolutionize the manner in
      which these patients are managed. The finding of reduced GI bleeding would allow the patient
      to have less exposure to blood products, reduce hospitalizations, and ensure that subsequent
      transplant planning not be delayed. This would not only be of great benefit to the patient,
      but would significantly decrease health-care costs through preventive measures.

      The goal of this project is to study whether the regular administration of monthly octreotide
      LAR is safe and if it will decrease the incidence of gastrointestinal bleeding in patients
      undergoing implantation of non-pulsatile, continuous flow left ventricular assist devices
      (LVAD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  LVAD insertion as bridge to transplant or destination

          -  18 years of age or older

        Exclusion Criteria:

          -  Poorly controlled diabetes, A1C greater than 8%

          -  Poorly controlled hypothyroidism, TSH > upper limit of normal (5.5)

          -  End Stage Renal Disease (ESRD) requiring dialysis

          -  Cirrhosis

          -  Anemia (Hgb < 8)

          -  Acromegaly

          -  Hx of chronic diarrhea - as determined by history of loose stool lasting longer than
             2-4 weeks

          -  Pregnancy or breastfeeding

          -  Inability to provide informed consent

          -  Incarceration or otherwise a ward of the state

          -  Non-English speaking