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

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ClinicalTrials.gov Identifier: NCT00111969
Recruitment Status : Completed
First Posted : May 27, 2005
Last Update Posted : July 4, 2006
Sponsor:
Information provided by:
Vasogen

Tracking Information
First Submitted Date  ICMJE May 26, 2005
First Posted Date  ICMJE May 27, 2005
Last Update Posted Date July 4, 2006
Study Start Date  ICMJE June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Mortality
  • Cardiovascular hospitalization
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00111969 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Clinical status
  • Health-related patient quality
  • Healthcare resource utilization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ACCLAIM - Advanced Chronic Heart Failure CLinical Assessment of Immune Modulation Therapy
Official Title  ICMJE 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
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Heart Failure, Congestive
Intervention  ICMJE Device: Celacade™ system
Study Arms  ICMJE Not Provided
Publications * Torre-Amione G, Anker SD, Bourge RC, Colucci WS, Greenberg BH, Hildebrandt P, Keren A, Motro M, Moyé LA, Otterstad JE, Pratt CM, Ponikowski P, Rouleau JL, Sestier F, Winkelmann BR, Young JB; Advanced Chronic Heart Failure CLinical Assessment of Immune Modulation Therapy Investigators. Results of a non-specific immunomodulation therapy in chronic heart failure (ACCLAIM trial): a placebo-controlled randomised trial. Lancet. 2008 Jan 19;371(9608):228-36. doi: 10.1016/S0140-6736(08)60134-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June 23, 2005)
2016
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE November 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female aged 18 or older.
  • New York Heart Association (NYHA) Class II to IV.
  • Left ventricular ejection fraction (LVEF) ≦ 30%, measured within the past six months (by any technique), unless there was a cardiovascular event that could have modified the LVEF during that period (e.g., coronary artery bypass grafting [CABG], myocardial infarction [MI]). If the patient was started on a beta-blocker or biventricular pacing (cardiac resynchronization therapy, or CRT), the LVEF measurement must have been at least three months after starting the therapy.
  • Hospitalized for heart failure; OR, received intravenous (IV) administration of an inotropic agent (therapeutic dose for HF), human B-natriuretic peptide, or IV diuretic (minimum 40 mg of furosemide or equivalent) in a clinic, outpatient or emergency department within the past 12 months (stable for at least 2 weeks). Exceptions: patients in NYHA Class III or IV who have a LVEF of < 25%.
  • On standard therapy for congestive heart failure (CHF), which must include angiotensin converting enzyme (ACE) inhibitors or angiotensin II receptor blocker (ARB) (unless contraindicated or patient is intolerant), with or without other appropriate agents. If on a beta-blocker, patient must have been on a beta-blocker for at least three months.
  • No changes in active cardiac medications for heart failure during the two weeks prior to randomization.
  • Written informed consent

Exclusion Criteria:

  • Inability to comply with the conditions of the protocol.
  • Presence of a transplanted tissue or organ or left ventricular assist device (LVAD) (or the expectation of the same within the next 12 months).
  • Planned Automatic Implantable Cardiac Defibrillator (AICD) or CRT within the next 12 months.
  • Acute MI, or CABG, percutaneous coronary intervention (PCI), AICD, or CRT within the past three months.
  • Need for chronic intermittent inotropic therapy.
  • Malignancy: evidence of disease within the previous five years. Exceptions: basal cell carcinoma, provided that it is neither infiltrating nor sclerosing, and carcinoma in situ of the cervix.
  • Active myocarditis or early postpartum cardiomyopathy (within the first six months of delivery).
  • Systemic corticosteroids, cytostatics, immunosuppressive drug therapy (cyclophosphamide, methotrexate, cyclosporine, azathioprine, etc.), and DNA depleting or cytotoxic drugs taken within four weeks prior to study treatment.
  • Pregnancy, or patients of childbearing potential not using adequate contraceptive methods.
  • Porphyria.
  • Allergy to sodium citrate or any “caine” type of local anesthetic.
  • Previous Celacade™ treatment.
  • Patient scheduled for hospice care.
  • Clinically relevant abnormal findings in the clinical history, physical examination, electrocardiogram (ECG), or laboratory tests at the screening assessment that would interfere with the objectives of the study or that would, in the investigator’s opinion, preclude safe completion of the study. Abnormal findings could include: known HIV infection or other immunodeficiency state, chronic active viral infection (such as hepatitis B or C), acute systemic infections (defined as patients undergoing treatment with antibiotics), gastrointestinal tract bleeding, or any severe or acute concomitant illness or injury.
  • Any other medical, social, or geographical factor that would make it unlikely that the patient could comply with study procedures (e.g., alcohol abuse, lack of permanent residence, severe depression, disorientation, distant location, or a history of noncompliance).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00111969
Other Study ID Numbers  ICMJE 0202
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Vasogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Andrea B Parker, PhD Vasogen Inc.
PRS Account Vasogen
Verification Date June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP