proportion of women, of those with preserved systolic function, and of those with hypertensive heart
disease.9
The results of Pre-RELAX-AHF need to be interpreted
in light of its exploratory nature, particularly in view of
the history of small heart-failure trials in which benets
turned out to be the play of chance.1012 The results are
probably too good to be true, in view of the lack of a
dose-dependent eect and the surprising eect of a
short treatment on postdischarge outcomes, including
180-day cardiovascular mortality (particularly with
just 12 cardiovascular deaths). In the nal analysis,
however, the signals that relaxin was reasonably safe
with trends of clinical improvement warrant further
investigation in proper outcomes studies. Beyond
showing the potential therapeutic value of relaxin, the
study highlights the challenge of clinical development
in acute heart failure. Acute heart failure is a
heterogeneous syndrome with distinct presentations,
which range from acute pulmonary congestion to
volume overload to low-output failure. A challenge for
trials in acute heart failure is to identify a population
of patients suited to the therapy against a background
of multiple comorbidities. Success of future trials will
Published Online
March 29, 2009
DOI:10.1016/S01406736(09)60653-X
See Articles page 1429
1401
Comment
AFH has received research grants from GlaxoSmithKline, Johnson & Johnson
(Scios, Inc), Medtronic, and Merck, and honoraria from AstraZeneca, Geron,
Medtronic, Novartis, Proventys, Thoratec, and ZyCare. CBG has received research
grants from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb,
GlaxoSmithKline, Novartis, Sano-Aventis, Roche, and The Medicines Company,
and has consulted for or received honoraria from AstraZeneca, deCODE Genetics,
GlaxoSmithKline, Novartis, Sano-Aventis, and The Medicines Company.
1
6
7
10
11
12
13
1402
Reproduced with permission of the copyright owner. Further reproduction prohibited without permission.