Tolvaptan For Worsening Outpatient Heart Failure: Role of Copeptin In Identifying Responders

Summary

Participation Requirements

Description

This study will be a randomized, double blind, positive control, multi-center clinical trial enrolling patients who present in the outpatient setting with signs and symptoms consistent with worsening congestive heart failure. The sample size for the study is 40 patients. Candidates for the study wil...

This study will be a randomized, double blind, positive control, multi-center clinical trial enrolling patients who present in the outpatient setting with signs and symptoms consistent with worsening congestive heart failure. The sample size for the study is 40 patients. Candidates for the study will be identified by screening outpatients presenting with worsening heart failure. Patients who qualify for the study will be enrolled within 24 hours of identification. Patients will be randomized in a 1:1 fashion to one of two treatment arms: Augmentation of current daily dose of oral loop diuretic + 30 mg of oral Tolvaptan daily Augmentation of current daily dose of oral loop diuretic + placebo of oral Tolvaptan daily Patients will initiate study medication in a hospital setting and will be observed for a period of time that will depend upon their baseline serum sodium and response to study drug. In most cases patients will be observed for 8 hours. Following this observational period, patients will leave the hospital setting and the remainder of the study will consist of follow-up by outpatient visits or by telephone. All patients will have Day 30 follow up phone contact for assessment of vital status, adverse events and morbidity during this period. The primary objectives of this study will be to compare the effects of oral tolvaptan plus augmented loop diuretic versus augmented loop diuretic on 1) short term changes in body weight with and without stratification for baseline copeptin and 2) an index targeted to signs and symptoms of congestion in patients presenting with worsening congestive heart failure in the outpatient setting with and without prespecified post hoc stratification based on baseline copeptin level.

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