Pilot Study of Using Copeptin to Predict Response to Tolvaptan
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
This pilot study will investigate the association between levels of the peptide copeptin and
response to tolvaptan, a drug that blocks the action of the water retaining hormone
vasopressin. The study will enroll stable outpatients with CHF with reduced LVEF (≤45)
selected by targeting upper and lower quartile copeptin levels at screening (10 each). The
treatment phase of the study will be a prospective, single-arm, open label protocol. All
patients will receive active therapy consisting of a single oral dose of 30 mg of tolvaptan
with body weight, fluid intake, and urine output monitored in a research unit for 24 hours.
For analysis of study endpoints, patients in the single intervention arm will be stratified
by a prospectively determined cut-point of copeptin level into two groups (≥10 versus <10
pmol/L). The copeptin level used for the two group stratification will be the blinded
copeptin value obtained at baseline from the hospital phase prior to administration of
tolvaptan.