Key result
Reading echocardiogram recordings with knowledge of sequence significantly overestimated the change in left ventricular mass compared to blinded reading (-19 ± 52 g vs -6 ± 53 g, P<0.01).
Why the study?
Does the mode of reading echocardiographic tracings (blinded vs unblinded to sequence) affect the measured regression of left ventricular mass in patients with LVH?
Population
Patients with left ventricular hypertrophy (LVH) enrolled in the LIVE study
Comparison
Indapamide SR 1.5 mg vs Enalapril 20 mg
Design
RCT, Echocardiograms read by experts blind to treatment and sequence
Authors
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Blinded echocardiogram reading prevents overestimation of LV mass regression; confirms requirement for sequence blinding in all future LVH trials.
Observational
Blind to treatment and sequence
Does the mode of reading echocardiographic tracings (blinded vs unblinded to sequence) affect the measured regression of left ventricular mass in patients with LVH?
Absolute Event Rate: -19% vs -6%
p-value: p=<0.01
Echocardiographic evaluation of left ventricular mass regression in clinical trials should be performed blinded to the sequence of examinations to prevent significant overestimation of treatment effects.
Gosse et al. (2003) conducted an observational in Left ventricular hypertrophy (LVH). Reading of recordings with knowledge of sequence vs. Reading blind to treatment and sequence was evaluated on Change in left ventricular mass (LVM) (p=<0.01). Reading echocardiogram recordings with knowledge of sequence significantly overestimated the change in left ventricular mass compared to blinded reading (-19 ± 52 g vs -6 ± 53 g, P<0.01).
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