PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ULARITIDE (URODILATIN) INTRAVENOUS INFUSION IN PATIENTS SUFFERING FROM ACUTE DECOMPENSATED HEART FAILURE (TRUE-AHF) - Protocol Number ULA01

Approval Date: 11/1/2012

Principal Investigator: Carol Clark, MD

The purpose of this study is to evaluate the efficacy and safety of a continuous intravenous (IV) ularitide infusion on the clinical status and outcome of patients with acute decompensated heart failure (ADHF). ADHF is a condition in which the heart has lost the ability to pump enough blood. Ularitide is an investigational drug meaning that it has not yet been approved by the FDA for use.

Eligibility:

Eligibility:

-          Ages 18-85

-          Emergency department presentation for ADHF

-          Ability to start drug infusion within 12 hours of first assessment by emergency department physician

Each study has its own guidelines to determine who can participate, called "eligibility criteria", with only the study doctor able to assess whether you meet all of the eligibility criteria.  More information can be found at http://clinicaltrials.gov/ct2/show/NCT01661634.

Contact Person:
Kristen McElreath (RO) Res Coordinator
248-898-3455

Blerina Pople (Troy) Res Coordinator
248-964-8168

Status of Clinical Trial:
open and enrolling