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

What Was Tested

In this phase 1 trial, researchers set out to test Octreotide.

Patients undergoing implantation of non-pulsatile, continuous-flow LVAD have a higher incidence of gastrointestinal bleeding.

It had 1 arm (groups): Octreotide LAR Depot (experimental).

The registry classes the interventions as drug.

More on the Plan

The primary specific aim is to determine the safety of octreotide LAR in patients with a LVAD.

Current therapies include lifestyle modification, medical management and revascularization via Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Surgery (CABG).

However, a large portion of patients develop cardiomyopathy which is refractory to the above interventions.

They are treated with chronic inotropes, resynchronization and other forms of medical management.

Who Took Part

The registry lists 10 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: LVAD insertion as bridge to transplant or destination. 18 years of age or older.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: poorly controlled hypothyroidism, tsh \> upper limit of normal (5.5); end stage renal disease (esrd) requiring dialysis; anemia (hgb \< 8).

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Octreotide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2013-02 with completion listed for 2014-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Participants With Side-Effects (time frame: 24 weeks).

It also tracked 1 secondary outcome, for example Need for Blood Transfusion and Hospital Admission for GI Bleed.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Octreotide in 10 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Octreotide compound page, all human trials.