Pilot Study of Using Copeptin to Predict Response to Tolvaptan
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|ClinicalTrials.gov Identifier: NCT01346072|
Recruitment Status : Completed
First Posted : May 2, 2011
Results First Posted : May 17, 2017
Last Update Posted : May 17, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cardiovascular Diseases Heart Diseases Heart Failure||Drug: tolvaptan||Phase 4|
The study screening strategy will be designed to enroll an enriched patient population by identifying patients at the high or low end of the spectrum of copeptin levels for outpatients with stable heart failure. This will be accomplished by blinded review of copeptin levels obtained during screening.
The primary endpoints for analysis will be 24 hour urine output and the change in body weight over 24 hours during the inpatient stay.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of the Relationship of Ambient Copeptin to the Aquaretic Effects of Tolvaptan in Patients With Heart Failure|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||December 2014|
Single arm study
oral, 30 mg, single dose, one time administration
Other Name: Samsca
- Urine Output [ Time Frame: 24 hours ]Total urine output for 24 hours following tolvaptan administration
- Body Weight [ Time Frame: Change over 24 hours ]Change in body weight from baseline to 24 hours after tolvaptan administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01346072
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27514|
|Principal Investigator:||Kirkwood F Adams, MD||University of North Carolina, Chapel Hill|