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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00111969
• Date of registration: 26/05/2005
• Primary sponsor: Vasogen
• Public title: ACCLAIM - Advanced Chronic Heart Failure CLinical Assessment of Immune Modulation Therapy
• Scientific title: 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
• Date of first enrolment: June 2003
• Target sample size: 2016
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00111969
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Contacts

• Name: Andrea B Parker, PhD
• Affiliation: Vasogen Inc.

Key inclusion & exclusion 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:

- 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Heart Failure, Congestive

Intervention(s)

Device: Celacade™ system

Primary Outcome(s)

Cardiovascular hospitalization

Mortality

Secondary Outcome(s)

Clinical status

Health-related patient quality

Healthcare resource utilization

Secondary ID(s)

0202

Source(s) of Monetary Support

Please refer to primary and secondary sponsors