Roche Announces Early Closure of Heart Failure Trial

Roche and study investigators at the Massachusetts General Hospital have announced that active enrollment into the Pro-BNP Outpatient Tailored Congestive Heart Failure Therapy (PROTECT) study has been stopped early based on a positive interim analysis.

PROTECT, a prospective randomized trial comparing a strategy of aggressive heart failure therapy guided by levels of a cardiac hormone – amino-terminal pro-B type natriuretic peptide (NT-proBNP) – versus standard heart failure treatment without NT-proBNP guidance has been enrolling subjects in the Heart Center at the Massachusetts General Hospital since 2006.

Commenting on the trial’s early suspension, lead investigator, Dr James Januzzi, Associate Professor of Medicine at Harvard Medical School and Director of the Cardiac Intensive Care Unit at the Massachusetts General Hospital said: “The data from the interim analysis of the study appear to indicate a significant difference between the treatment arms in favor of the NT-proBNP group.”

Concentrations of the hormone are known to be predictive of future risk in chronic heart failure. However, while therapies for heart failure that improve patient outcomes are known to lower NT-proBNP values, the strategy to actively “guide” heart failure therapy by combining standard clinical titration of medications together with a targeted strategy to lower NT-proBNP values (with the hope to reduce events further than heart failure therapy guided by clinical judgment alone) remains to be proven.

The trial is now closed. Final patient visits will be carried out and final data will be collected to allow a full analysis. Final results of the study will be presented and published in 2010, once the analysis is complete.