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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Virginia Commonwealth University
Sponsor:
Collaborators:
Thoratec Corporation
Novartis
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01707225
First received: October 11, 2012
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Gastrointestinal Bleeding
Drug: Octreotide LAR Depot
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Octreotide LAR Depot in Left Ventricular Assist Device (LVAD) Associate Gastrointestinal (GI)

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • The primary specific aim is to determine the safety of octreotide LAR in patients with a LVAD. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Patient experience of certain cardiovascular, CNS, dermatologic, endocrine and metabolic, GI, Hematologic, Neurologic, renal, and respiratory symptoms will be recorded throughout the study


Secondary Outcome Measures:
  • Our key secondary outcomes will focus on study drug efficacy. Patient experience of the following will be assessed: Need for Blood Transfusion Hospital Admission for GI Bleed [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01707225

Contacts
Contact: Christine DeWilde, RN 804-628-5710 dewildect@vcu.edu

Locations
United States, Virginia
Virginia Commonwealth University Health System Recruiting
Richmond, Virginia, United States, 23298
Contact: Rajiv Malhotra    804-828-9071      
Contact: Chris DeWilde, RN    804-628-5710    dewildect@vcu.edu   
Sponsors and Collaborators
Virginia Commonwealth University
Thoratec Corporation
Novartis
Investigators
Principal Investigator: Rajiv Malhotra, DO MS VCU
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01707225     History of Changes
Other Study ID Numbers: HM14516
Study First Received: October 11, 2012
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Virginia Commonwealth University:
GI Bleeding
Gastrointestinal bleeding
LVAD

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Digestive System Diseases
Gastrointestinal Diseases
Pathologic Processes
Octreotide
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014