Advanced Chronic Heart Failure Clinical Assessment Of Immune Modulation Therapy
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Complete Title of Study
Complete Title of Study
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
Study Acronym (The trial’s abbreviation if there is one)
Study Acronym (The trial’s abbreviation if there is one)
ACCLAIM
Principal Investigator, Co-investigators, and Collaborating Institutions
Principal Investigator, Co-investigators, and Collaborating Institutions
Study director: Andrea B Parker, PhD
Institution: Vasogen Inc.
Overview of Trial
Overview of Trial
The goal of the study was 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.
Disease State(s) Studied (e.g. acute MI, breast cancer, etc.)
Disease State(s) Studied (e.g. acute MI, breast cancer, etc.)
Heart failure, congestive
Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here
Study Phase (e.g. Phase I,II,III,IV) Study Phases are defined here
Phase III
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Phase I Trials
These are initial studies to determine the metabolism and pharmacologic actions of drugs in humans (what are called PK/PD studies or pharmacokinetic / pharmacodynamic studies), the side effects associated with increasing doses (a dose response curve or dose response relationship), and to gain early evidence of effectiveness; may include healthy participants and/or patients. These are sometimes called a first in man study.
Phase II Trials
Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks. Sometimes multiple doses will be studied in these trials to select the appropriate dose for further testing in phase III. These are sometimes called a dose finding study.
Phase III Trials
Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling. These are also called pivotal trials.
Phase IV Trials
After the drug has been approved by a regulatory agency, these are post-marketing studies to delineate additional information including the drug’s risks,benefits, and optimal use in a broader group of real world patients.
Study Design (e.g. multicenter, randomized, double blind, placebo controlled)
Study Design (e.g. multicenter, randomized, double blind, placebo controlled)
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Study Arms and How They Were Treated (Intervention) (Explanation here)
Study Arms and How They Were Treated (Intervention) (Explanation here)
2,016 patients were randomized to either placebo or an immune modulation therapy device (the Celacade™ system).
Primary Pre-Specified Endpoints
Primary Pre-Specified Endpoints
- Mortality
- Cardiovascular hospitalization
Secondary Endpoints
Secondary Endpoints
- Clinical status
- Health-related patient quality
- Healthcare resource utilization
Inclusion Criteria
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
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).
Outcome: Primary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
Outcome: Primary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported
Outcome: Secondary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
Outcome: Secondary endpoint (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported
Outcome: Exploratory endpoints (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
Outcome: Exploratory endpoints (Report both relative risk reduction and absolute risk reduction as well as number needed to treat if available)
None reported
Outcome: Safety endpoints (Report both relative risk and absolute risk as well as number needed to harm if available)
Outcome: Safety endpoints (Report both relative risk and absolute risk as well as number needed to harm if available)
None reported
Conclusions of the Investigators (Quote the investigators conclusions here)
Conclusions of the Investigators (Quote the investigators conclusions here)
None reported
Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
Commentary, Discussion and Limitations of the Trial (Anyone can add comments)
None reported
Slides
Slides
None reported
Video Commentary
Video Commentary
None reported
External sites for further information (How to insert links)
External sites for further information (How to insert links)
Detailed information about the trial
Detailed information about the trial
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.
Ages
Ages
18 years and older
Gender (Indicate whether men, women or both were enrolled)
Gender (Indicate whether men, women or both were enrolled)
Both men and women were eligible for the study
Accepts Healthy Volunteers (Answer yes or no)
Accepts Healthy Volunteers (Answer yes or no)
No
Enrollment Period (Study start and end date)
Enrollment Period (Study start and end date)
Study start date: June 2003
Estimated study completion date: November 2005
Recruitment Status (explanation)
Recruitment Status (explanation)
Study has been completed.
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]
Recruitment status indicates the current stage of a trial, whether it is planned, ongoing, or completed. Possible values include:
- Not yet recruiting: participants are not yet being recruited or enrolled
- Recruiting: participants are currently being recruited and enrolled
- Enrolling by invitation: participants are being (or will be) selected from a predetermined population
- Active, not recruiting: study is ongoing (i.e., patients are being treated or examined), but enrollment has completed
- Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient’s last visit has occurred)
- Suspended: recruiting or enrolling participants has halted prematurely but potentially will resume
- Terminated: recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated
- Withdrawn: study halted prematurely, prior to enrollment of first participant
Enrollment (Total number of patients enrolled)
Enrollment (Total number of patients enrolled)
2,016
Study Sponsor (e.g. Investigator initiated or company name)
Study Sponsor (e.g. Investigator initiated or company name)
Vasogen
Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)
Source of Data (Where is this data on this page coming from: publication, principal investigator, or co-investigator)
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