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

NCT01707225 | Completed Phase 1 Results DMC

• 1 other identifier: HM14516
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Gastrointestinal Bleeding

Keywords

GI Bleeding; Gastrointestinal bleeding; LVAD

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Side-Effects

  Cardiovascular: 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%) Dermatologic: Pruritus (≤18%) Rash (15%; depot formulation) alopecia (≤13%) Endocrine \& metabolic: Hyperglycemia (2% to 27%) Gastrointestinal: 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%) Local: 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%) Respiratory: Upper respiratory infection (10% to 23%) Miscellaneous: flu symptoms (1% to 20%)

  24 weeks

Secondary Outcomes (1)

• Need for Blood Transfusion and Hospital Admission for GI Bleed

  24 weeks

Study Arms (1)

Octreotide LAR Depot

EXPERIMENTAL

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

Interventions

Octreotide LAR Depot DRUG

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.

Octreotide LAR Depot

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• LVAD insertion as bridge to transplant or destination
• years of age or older

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Thoratec Corporation: collaborator
• Novartis: collaborator

Study Sites (1)

Virginia Commonwealth University Health System

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Rajiv Malhotra, DO
• Organization: Virginia Commonwealth University

rajiv.malhotra@vcuhealth.org

804-828-9071

Study Officials

• Rajiv Malhotra, DO MS

  VCU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: October 16, 2012
• Study Start: February 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: February 3, 2017
• Results First Posted: January 12, 2016

Record last verified: 2016-12

Locations

US (1)