Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT01707225Other idHM14516

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 10 participants (actual)
Sponsor: Virginia Commonwealth University · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: Feb 2013
Primary completion: Oct 2014
Completion: Oct 2014
First posted: 16 Oct 2012 (estimated)
Last update posted: 3 Feb 2017 (estimated)
Conditions: Gastrointestinal Bleeding

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201320142015

Ph 1
Safety Study of Octreotide Injection to Prevent GI Bleeding in Patients With Left Ventricular Assist Device (LVAD)
NCT01707225
Feb 2013 to Oct 2014

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

Octreotide LAR DepotDrug

Arms1

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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With Side-Effects
Time frame · 24 weeks
Registry description
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(1)

Need for Blood Transfusion and Hospital Admission for GI Bleed
Time frame · 24 weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 24 weeks

Number of Participants With Side-Effects

Group	Value (participants)
Octreotide LAR Depot	10

Secondary and other outcome results(1)

Secondary outcomeNumber· 24 weeks

Need for Blood Transfusion and Hospital Admission for GI Bleed

Group	Value (participants)
Octreotide LAR Depot	10

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Octreotide LAR DepotOnce enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks. Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for 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.	–	0 / 10	0 / 10

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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

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