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Safety Study of Octreotide Injection to Prevent GI Bleeding in Patients With Left Ventricular Assist Device (LVAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01707225
Recruitment Status : Completed
First Posted : October 16, 2012
Results First Posted : January 12, 2016
Last Update Posted : February 3, 2017
Thoratec Corporation
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief 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).

Condition or disease Intervention/treatment Phase
Gastrointestinal Bleeding Drug: Octreotide LAR Depot Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Octreotide LAR Depot in Left Ventricular Assist Device (LVAD) Associate Gastrointestinal (GI)
Study Start Date : February 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Octreotide LAR Depot
Once enrolled in the study subjects will receive a monthly intra-muscular injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.
Drug: Octreotide LAR Depot
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.

Primary Outcome Measures :
  1. Number of Participants With Side-Effects [ Time Frame: 24 weeks ]


    Sinus bradycardia (19% to 25%) Hypertension (≤13%) conduction abnormalities (9% to 10%)

    Central nervous system:

    Fatigue (1% to 32%) headache (6% to 30%) malaise (16% to 20%) fever (16% to 20%) dizziness (5% to 20%) Pain (4% to 15%)


    Pruritus (≤18%) Rash (15%; depot formulation) alopecia (≤13%)

    Endocrine & metabolic:

    Hyperglycemia (2% to 27%)


    Abdominal pain (5% to 61%) loose stools (5% to 61%) nausea (5% to 61%) diarrhea (34% to 58%) flatulence (≤38%) cholelithiasis (13% to 38%; length of therapy dependent) constipation (9% to 21%) vomiting (4% to 21%)

    Hematologic Anemia (5-15%)


    Injection site pain (2% to 50%; dose and formulation related)

    Neuromuscular & skeletal:

    Back pain (1% to 27%) arthropathy (8% to 19%) myalgia (≤18%)

    Renal Kidney Stones (5-15%)


    Upper respiratory infection (10% to 23%)


    flu symptoms (1% to 20%)

Secondary Outcome Measures :
  1. Need for Blood Transfusion and Hospital Admission for GI Bleed [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01707225

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United States, Virginia
Virginia Commonwealth University Health System
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Thoratec Corporation
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Principal Investigator: Rajiv Malhotra, DO MS VCU

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Responsible Party: Virginia Commonwealth University Identifier: NCT01707225    
Other Study ID Numbers: HM14516
First Posted: October 16, 2012    Key Record Dates
Results First Posted: January 12, 2016
Last Update Posted: February 3, 2017
Last Verified: December 2016
Keywords provided by Virginia Commonwealth University:
GI Bleeding
Gastrointestinal bleeding
Additional relevant MeSH terms:
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Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents