Idioventricular rhythm: hypervagotonia associated with placebo.
We report a case of hypervagotonia manifested by idioventricular rhythm in a healthy, athletic man who participated in a Phase I study of an investigational calcium-channel blocker. Upon breaking the study's double-blind study code, it was discovered that the subject had received placebo. We discuss this unusual finding and the implications of including athletic subjects in safety/tolerance studies.
Cutler
N R
NR
California Clinical Trials, Beverly Hill, CA.
Heller
A H
AH
Kurtz
N M
NM
Sramek
J J
JJ
Lynch
T E
TE
Zolnouni
P P
PP
Gandhi
D K
DK
Sawin
S
S
D016170:Accelerated Idioventricular Rhythm / Q000139:chemically induced*; D000328:Adult; D003389:Cranial Nerve Diseases / Q000139:chemically induced; D004311:Double-Blind Method; D004562:Electrocardiography / Q000187:drug effects; D006801:Humans; D008297:Male; D010919:Placebos / Q000009:adverse effects*; D014630:Vagus Nerve / Q000187:drug effects*
D010919:Placebos