NCT01661634

Efficacy and Safety of Ularitide for the Treatment of Acute Decompensated Heart Failure

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]

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,157 (actual)
• Sponsor: Cardiorentis · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The objective of the TRUE-AHF study is to evaluate the effect of a 48-h continuous IV infusion of ularitide (15 ng/kg/min) versus placebo on the clinical status of patients with acute decompensated heart failure (ADHF). The study drug will be administered in addition to the standard treatment. The nature of standard therapy will be carried out according to the clinical judgment of the Investigator and may include vasodilator, inotropic, and diuretic drugs, as clinically indicated. There are two co-primary endpoints for this study. Co-primary endpoint 1 will be a hierarchical clinical composite variable that includes a patient-centered assessment of clinical progress, an assessment of lack of improvement or worsening of HF requiring a pre-specified intervention, and death. The endpoint is intended to mimic the assessment that would be carried out by a physician caring for the patient. If, during the 48 h infusion, a patient's clinical course deteriorates because he/she dies, fails to improve or develops worsening HF requiring a pre-specified intervention or if the patient considers his/her general clinical status as moderately or markedly worse, the patient will be considered to be "worse". If the patient considers his/her general clinical status as moderately or markedly improved and if such improvement is sustained without fulfilling the criteria for "worse" throughout the 48-h infusion (from 0 h to 48 h), the patient will be considered to be "improved". If the patient is neither improved nor worse, the patient's clinical status will be considered to be "unchanged". Co-primary efficacy endpoint 2 evaluates freedom from cardiovascular mortality during follow up after randomization, for the entire duration of the trial.

Conditions

• Acute Decompensated Heart Failure

Interventions

Type	Name	Description
DRUG	Ularitide
DRUG	Placebo

Timeline

• Start date: 2012-07-01
• Primary completion: 2015-11-01
• Completion: 2016-03-01
• First posted: 2012-08-09
• Last updated: 2018-10-23

Locations

163 sites across 22 countries: United States, Argentina, Belgium, Brazil, Canada, Czechia, Estonia, Finland, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, Poland, Romania, Serbia, Spain, Switzerland, Turkey (Türkiye)