title: Mode of death and hospitalization from the Second Follow-up Serial Infusions of Nesiritide (FUSION II) trial and comparison of clinical events committee adjudicated versus investigator reported outcomes.
abstract: The aim of this study was to evaluate the mode of death and hospitalizations in advanced heart failure (HF) patients with renal dysfunction and to examine the rate of concordance between events reported by the clinical events committee and site investigators (using case report forms) in the Second Follow-Up Serial Infusions of Nesiritide (FUSION II) trial. Little is known about the cause of death and hospitalization in patients with advanced HF. FUSION II was a randomized, double-blind, placebo-controlled trial evaluating outpatient nesiritide infusions versus placebo, with 911 patients with advanced HF (New York Heart Association class III or IV) and renal dysfunction enrolled. There were 151 deaths and 1,041 hospitalizations at 24 weeks. The clinical events committee classified events as cardiac, renal, cardiorenal, other or noncardiovascular, or unknown. Kappa statistics and McNemar tests were used to assess agreement (overall and by individual modes of death and hospitalization indications). In conclusion, the most common cause of death or hospitalization was cardiac related, with 70% of deaths and 60% of hospitalizations due to cardiac causes. There was 74% agreement (26% disagreement) on cardiac cause of death (κ = 0.40, McNemar p = 0.001) and 75% agreement (25% disagreement) between the investigators and the clinical events committee on cardiac classification for hospitalization (κ = 0.49, McNemar p <0.0001).
authors: Duke University Medical Center, Durham, North Carolina, USA. oconn002@mc.duke.edu
authors: Christopher M
authors: CM
authors: O'Connor
authors: Mona
authors: M
authors: Fiuzat
authors: Joann
authors: J
authors: Lindenfeld
authors: Alan
authors: A
authors: Miller
authors: Carlo
authors: C
authors: Lombardi
authors: Peter
authors: P
authors: Carson
authors: Linda K
authors: LK
authors: Shaw
authors: Li-Joy
authors: LJ
authors: Wang
authors: Patricia
authors: P
authors: Connolly
authors: Roger
authors: R
authors: Mills
authors: Clyde
authors: C
authors: Yancy
authors: Kenneth
authors: K
authors: Mahaffey
mesh_terms: D000368:Aged; D002423:Cause of Death; D026661:Clinical Trials Data Monitoring Committees; D004311:Double-Blind Method; D005260:Female; D006333:Heart Failure / Q000401:mortality*; D006760:Hospitalization / Q000706:statistics & numerical data*; D006801:Humans; D007260:Infusion Pumps; D008297:Male; D008875:Middle Aged; D045283:Natriuretic Agents / Q000008:administration & dosage; D020097:Natriuretic Peptide, Brain / Q000008:administration & dosage; D011446:Prospective Studies; D051437:Renal Insufficiency / Q000453:epidemiology; D012108:Research Personnel
chemical_list: D045283:Natriuretic Agents; D020097:Natriuretic Peptide, Brain