Safety Study of Octreotide Injection to Prevent GI Bleeding in Patients With Left Ventricular Assist Device (LVAD)
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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) |
- 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
- 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: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (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 |
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| Contact: Christine DeWilde, RN | 804-628-5710 | dewildect@vcu.edu |
| 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 | |
| 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: | March 4, 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 Gastrointestinal Diseases Digestive System Diseases Pathologic Processes Octreotide |
Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents |
ClinicalTrials.gov processed this record on May 19, 2013