PMID- 15364317
OWN - NLM
STAT- MEDLINE
DCOM- 20041021
LR  - 20151119
IS  - 0735-1097 (Print)
IS  - 0735-1097 (Linking)
VI  - 44
IP  - 6
DP  - 2004 Sep 15
TI  - Effects of a novel immune modulation therapy in patients with advanced chronic 
      heart failure: results of a randomized, controlled, phase II trial.
PG  - 1181-6
AB  - OBJECTIVE: We sought to determine whether a novel, non-pharmacological form of 
      immune modulation therapy (IMT), shown experimentally to reduce inflammatory and 
      increase anti-inflammatory cytokines, improved outcomes in patients with advanced 
      heart failure (HF). BACKGROUND: Immune activation contributes to the progression 
      of HF, but treatments directed against inflammation have been largely 
      unsuccessful. METHODS: Seventy-five HF patients (New York Heart Association 
      [NYHA] functional class III to IV) were randomized to receive either IMT (n = 38) 
      or placebo (n = 37) in a double-blind trial for six months, with continuation of 
      standard HF therapy. Patients were evaluated using the 6-min walk test, changes 
      in NYHA functional class, cardiac function, and quality of life assessments, as 
      well as occurrence of death and hospitalization. RESULTS: There was no 
      between-group difference in 6-min walk test, but 15 IMT patients (compared with 9 
      placebo) improved NYHA functional classification by at least one class (p = 
      0.140). The Kaplan-Meier survival analysis showed that IMT significantly reduced 
      the risk of death (p = 0.022) and hospitalization (p = 0.008). Analysis of a 
      clinical composite score demonstrated a significant between-group difference (p = 
      0.006). There was no difference in left ventricular ejection fraction, but there 
      was a trend toward improved quality of life (p = 0.110). CONCLUSIONS: These 
      preliminary findings are consistent with the hypothesis that immune activation is 
      important in the pathogenesis of HF and establish the basis for a phase III trial 
      to define the benefit of IMT in chronic HF.
FAU - Torre-Amione, Guillermo
AU  - Torre-Amione G
AD  - Methodist DeBakey Heart Center, Baylor College of Medicine, Houston, Texas 77030, 
      USA. gtorre@bcm.tmc.edu
FAU - Sestier, Francois
AU  - Sestier F
FAU - Radovancevic, Branislav
AU  - Radovancevic B
FAU - Young, James
AU  - Young J
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Am Coll Cardiol
JT  - Journal of the American College of Cardiology
JID - 8301365
RN  - 0 (Biomarkers)
SB  - IM
MH  - Aged
MH  - Biomarkers/blood
MH  - Chronic Disease
MH  - Female
MH  - Heart Failure/*immunology/physiopathology/*therapy
MH  - Humans
MH  - *Immunotherapy
MH  - Male
MH  - Middle Aged
MH  - Stroke Volume/physiology
MH  - Survival Analysis
MH  - Treatment Outcome
EDAT- 2004/09/15 05:00
MHDA- 2004/10/22 09:00
CRDT- 2004/09/15 05:00
PHST- 2004/01/15 00:00 [received]
PHST- 2004/06/03 00:00 [revised]
PHST- 2004/06/14 00:00 [accepted]
PHST- 2004/09/15 05:00 [pubmed]
PHST- 2004/10/22 09:00 [medline]
PHST- 2004/09/15 05:00 [entrez]
AID - S0735-1097(04)01322-1 [pii]
AID - 10.1016/j.jacc.2004.06.047 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2004 Sep 15;44(6):1181-6. doi: 10.1016/j.jacc.2004.06.047.