Tolvaptan for Advanced or Refractory Heart Failure

Heart Failure Clinical Trial

Official title: Tolvaptan for the Management of Acute Decompensated Heart Failure in Patients With Advanced or Refractory Heart Failure

Status Terminated

Clinical Trial Summary

This study will clarify the clinical usefulness of Tolvaptan therapy in patients with complicated acute decompensated heart failure and hyponatremia (low blood sodium).

Clinical Trial Description

Despite its demonstrated efficacy and tolerability, Tolvaptan remains underutilized for the treatment of acute decompensated heart failure (ADHF) in many centers. Post-hoc analysis suggests that Tolvaptan may provide optimal outcomes in patients with more advanced heart failure (HF) including those with cardiorenal syndrome, marked hyponatremia and severe congestion, or a combination of those conditions. The efficacy of Tolvaptan in HF patients with loop diuretic resistance and in those requiring inotropic support remains uncertain.

The purpose of this study is to examine the benefit of Tolvaptan versus the current standard of care diuretic therapy for patients hospitalized with ADHF and evidence of advanced or complex HF with severe hyponatremia. Patients with advanced or complex disease are defined as those with suboptimal diuretic response over a 48 hour period. ;

Related Conditions & MeSH terms

• Heart Failure
• Hyponatremia

• NCT number: NCT02959411
• Study type: Interventional
• Source: University of Calgary
• Status: Terminated
• Phase: Phase 4
• Start date: October 2016
• Completion date: June 30, 2020