Echocardiography in multicenter clinical trials: Experience from the treatment of mild hypertension study

Echocardiography is becoming commonplace in clinical trials relating to hypertension for assessing changes in left ventricular mass (LVM). Factors affecting variability need to be considered in the design and management of such studies. These include (1) standardization of recordings and readings, (2) quality of recordings, (3) choice of sonographer vs. cardiologist readers, and (4) reader and temporal variability in measurements. The Treatment of Mild Hypertension Study (TOMHS) provides data and experience concerning these issues.