Targeting Acute Congestion With Tolvaptan in Congestive Heart Failure — TACTICS-HF  

Heart Failure Clinical Trial

Official title: The Targeting Acute Congestion With Tolvaptan In Congestive Heart Failure Study

Status Completed

Clinical Trial Summary

The purpose of this study is to see if taking tolvaptan by mouth in addition to the regular treatment received for shortness of breath due to heart failure will work better than the regular treatment alone. The study will also look to see if other symptoms of heart failure or problems associated with heart failure treatments, like changes in kidney function, are affected by tolvaptan.

The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will be more effective at relieving dyspnea than fixed dose furosemide alone.

Clinical Trial Description

This study will be a randomized, double blind, placebo controlled, multi-center clinical trial of patients with signs and symptoms consistent with acute heart failure (AHF) within 24 hours of presentation at Emergency Department. A total of approximately 250 patients will be enrolled in the trial.

Patients will be randomized in a 1:1 ratio to either of 2 treatment regimens:

• Fixed-dose IV furosemide (1 x total daily oral dose) given intravenously in divided doses every 12 hours or 40 mg IV Q12 hours, whichever is greater + oral Tolvaptan (given at 0, 12, 24 and 48 hours)

• Fixed-dose IV furosemide (1 x total daily oral dose) given intravenously in divided doses every 12 hours or 40 mg IV Q12 hours, whichever is greater + oral placebo (given at 0, 12, 24 and 48 hours)

The study treatment regimen will be administered from randomization through 48 hours, at which point Tolvaptan/placebo will be discontinued and all diuretic treatment will be adjusted at the treating physician's discretion.

The primary endpoint will be the proportion of patients with at least moderate improvement in dyspnea by Likert scale at both 8 AND 24 hours AND without the need for escalation of therapy due to worsening heart failure (rescue therapy) or death within 24 hours.

Patients will be followed daily for the duration of hospitalization or for 7 days (whichever is shortest).

All patients will have Day 30 follow up phone contact for assessment of vital status and interval hospitalizations. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyspnea
• Heart Failure

• NCT number: NCT01644331
• Study type: Interventional
• Source: Duke University
• Status: Completed
• Phase: Phase 3
• Start date: October 2012
• Completion date: February 2016