NCT02646540

AiDing Diuresis wIth Tolvaptan (ADD-IT)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the use of tolvaptan (commercial name Samsca) when given in addition to intravenous (IV) diuretics early during an episode of acute heart failure. It will be compared to a high dose of IV diuretics alone or the use of metolazone in addition to IV diuretics. The investigators are looking to see if there is improvement in the symptoms and outcomes of persons with acute heart failure.

Detailed description

This is a single-center, randomized trial to assess the effects of 30 mg daily of tolvaptan when given concomitantly with home dose of diuretic (Lasix equivalent) intravenously (IV) versus 5mg daily of metolazone given concomitantly with home dose of diuretic (Lasix equivalent) IV, versus 2.5 times home dose of diuretic (Lasix equivalent) IV in participants hospitalized for acutely decompensated heart failure (ADHF).

Conditions

• Cardiomyopathy
• Congestive Heart Failure

Interventions

Type	Name	Description
DRUG	Tolvaptan 30 mg + IV Diuretics	Participants will receive oral daily tolvaptan 30 mg concomitantly with their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.
DRUG	Metolazone 5 mg + IV Diuretics	Participants will receive oral daily metolazone 5 mg concomitantly with their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.
DRUG	2.5 times the Diuretics Dose	Participants will receive two and a half (2.5) times their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.

Timeline

• Start date: 2016-01-01
• Primary completion: 2018-12-30
• Completion: 2018-12-30
• First posted: 2016-01-05
• Last updated: 2019-03-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study