PMID- 18207018
OWN - NLM
STAT- MEDLINE
DCOM- 20080131
LR  - 20150616
IS  - 1474-547X (Electronic)
IS  - 0140-6736 (Linking)
VI  - 371
IP  - 9608
DP  - 2008 Jan 19
TI  - Results of a non-specific immunomodulation therapy in chronic heart failure 
      (ACCLAIM trial): a placebo-controlled randomised trial.
PG  - 228-36
LID - 10.1016/S0140-6736(08)60134-8 [doi]
AB  - BACKGROUND: Evidence suggests that inflammatory mediators contribute to 
      development and progression of chronic heart failure. We therefore tested the 
      hypothesis that immunomodulation might counteract this pathophysiological 
      mechanism in patients. METHODS: We did a double-blind, placebo-controlled study 
      of a device-based non-specific immunomodulation therapy (IMT) in patients with 
      New York Heart Association (NYHA) functional class II-IV chronic heart failure, 
      left ventricular (LV) systolic dysfunction, and hospitalisation for heart failure 
      or intravenous drug therapy in an outpatient setting within the past 12 months. 
      Patients were randomly assigned to receive IMT (n=1213) or placebo (n=1213) by 
      intragluteal injection on days 1, 2, 14, and every 28 days thereafter. Primary 
      endpoint was the composite of time to death from any cause or first 
      hospitalisation for cardiovascular reasons. The study continued until 828 primary 
      endpoint events had accrued and all study patients had been treated for at least 
      22 weeks. Analysis was by intention to treat. This study is registered with 
      ClinicalTrials.gov, number NCT00111969. FINDINGS: During a mean follow-up of 10.2 
      months, there were 399 primary events in the IMT group and 429 in the placebo 
      group (hazard ratio 0.92; 95% CI 0.80-1.05; p=0.22). In two prespecified 
      subgroups of patients--those with no history of previous myocardial infarction 
      (n=919) and those with NYHA II heart failure (n=689)--IMT was associated with a 
      26% (0.74; 0.57-0.95; p=0.02) and a 39% (0.61; 95% CI 0.46-0.80; p=0.0003) 
      reduction in the risk of primary endpoint events, respectively. INTERPRETATION: 
      Non-specific immunomodulation may have a role as a potential treatment for a 
      large segment of the heart failure population, which includes patients without a 
      history of myocardial infarction (irrespective of their functional NYHA class) 
      and patients within NYHA class II.
FAU - Torre-Amione, Guillermo
AU  - Torre-Amione G
AD  - Heart Transplant Program, Methodist DeBakey Heart Center, Methodist Hospital, 
      Houston, TX 77030, USA. gtorre@tmhs.org
FAU - Anker, Stefan D
AU  - Anker SD
FAU - Bourge, Robert C
AU  - Bourge RC
FAU - Colucci, Wilson S
AU  - Colucci WS
FAU - Greenberg, Barry H
AU  - Greenberg BH
FAU - Hildebrandt, Per
AU  - Hildebrandt P
FAU - Keren, Andre
AU  - Keren A
FAU - Motro, Michael
AU  - Motro M
FAU - Moye, Lemuel A
AU  - Moye LA
FAU - Otterstad, Jan Erik
AU  - Otterstad JE
FAU - Pratt, Craig M
AU  - Pratt CM
FAU - Ponikowski, Piotr
AU  - Ponikowski P
FAU - Rouleau, Jean Lucien
AU  - Rouleau JL
FAU - Sestier, Francois
AU  - Sestier F
FAU - Winkelmann, Bernhard R
AU  - Winkelmann BR
FAU - Young, James B
AU  - Young JB
CN  - Advanced Chronic Heart Failure CLinical Assessment of Immune Modulation Therapy 
      Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00111969
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Lancet
JT  - Lancet (London, England)
JID - 2985213R
RN  - 0 (Immunologic Factors)
SB  - IM
CIN - Lancet. 2008 Jan 19;371(9608):184-6. PMID: 18207004
CIN - Lancet. 2008 Jun 21;371(9630):2083; author reply 2084. PMID: 18572074
CIN - Lancet. 2008 Jun 21;371(9630):2083; author reply 2084. PMID: 18572075
CIN - Forsch Komplementmed. 2008 Aug;15(4):230. PMID: 18795463
MH  - Aged
MH  - Chronic Disease
MH  - Double-Blind Method
MH  - Endpoint Determination/*methods
MH  - Female
MH  - Heart Failure/classification/physiopathology/*therapy
MH  - Hospital Mortality
MH  - Humans
MH  - Immunologic Factors/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Severity of Illness Index
EDAT- 2008/01/22 09:00
MHDA- 2008/02/01 09:00
CRDT- 2008/01/22 09:00
PHST- 2008/01/22 09:00 [pubmed]
PHST- 2008/02/01 09:00 [medline]
PHST- 2008/01/22 09:00 [entrez]
AID - S0140-6736(08)60134-8 [pii]
AID - 10.1016/S0140-6736(08)60134-8 [doi]
PST - ppublish
SO  - Lancet. 2008 Jan 19;371(9608):228-36. doi: 10.1016/S0140-6736(08)60134-8.