NCT00111969

ACCLAIM - Advanced Chronic Heart Failure CLinical Assessment of Immune Modulation Therapy

A Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess the Effects of the Celacade™ System on Mortality and Morbidity in Patients With Chronic Heart Failure

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,016 (planned)
• Sponsor: Vasogen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the safety and efficacy of the Celacade™ system in reducing the risk of mortality and cardiovascular hospitalizations in patients with chronic systolic heart failure.

Detailed description

Evidence continues to accumulate on the importance of inflammation in the development and progression of heart failure (HF). The Celacade™ system may reduce chronic inflammation by stimulating the immune system's physiological anti-inflammatory response. The ACCLAIM study is an international, approximately 2,000-patient, Phase III clinical research study designed to test the safety and efficacy of the Celacade™ system in reducing the risk of mortality and cardiovascular hospitalizations in patients with chronic systolic HF.

Conditions

• Heart Failure, Congestive

Interventions

Type	Name	Description
DEVICE	Celacade™ system

Timeline

• Start date: 2003-06-01
• Completion: 2005-11-01
• First posted: 2005-05-27
• Last updated: 2006-07-04