Safety and Efficacy of Octreotide LAR Depot in Left Ventricular Assist Device (LVAD) Associate Gastrointestinal (GI)
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Number of Participants With Side-Effects
Study Overview
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).
Detailed Description
The primary specific aim is to determine the safety of octreotide LAR in patients with a LVAD.
Patient experience of the following will be assessed throughout the study (list obtained from up-to-date.com)
Cardiovascular:
Sinus bradycardia (19% to 25%) Hypertension (≤13%) conduction abnormalities (9% to 10%)
Central nervous system:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
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.
Intervention: Octreotide LAR Depot (Drug)
Outcomes
Primary Outcomes
Number of Participants With Side-Effects
Time Frame: 24 weeks
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%)
Secondary Outcomes
- Need for Blood Transfusion and Hospital Admission for GI Bleed(24 weeks)