NCT02959411

Tolvaptan for Advanced or Refractory Heart Failure

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Heart Failure
• Hyponatremia

Interventions

Type	Name	Description
DRUG	Tolvaptan	Tolvaptan is a selective vasopressin receptor antagonist that inhibits activation of the V2 receptor and synthesis and insertion of the aquaporin2 channel into the apical membrane of the renal collecting duct. Tolvaptan inhibits the reabsorption of free water, inducing free water diuresis and increasing serum sodium levels without adversely influencing electrolyte levels or stimulating the sympathetic nervous system or renin-angiotensin system.
DRUG	Standard of care diuretic therapy	Usual standard of care diuretic therapy for patients hospitalized with acute decompensated heart failure

Timeline

• Start date: 2016-10-01
• Primary completion: 2020-06-30
• Completion: 2020-06-30
• First posted: 2016-11-09
• Last updated: 2020-07-27

Locations

1 site across 1 country: Canada