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BNP for CHF Dr James Young Head, Section of Heart Failure and Cardiac Transplant Medicine Cleveland Clinic Foundation Cleveland, OH BNP for CHF B-type natriuretic peptide nesiritide (B-type natriuretic peptide) Hormone produced by the left ventricle in response to increase in volume and pressure in the left ventricle. A potent vasodilator, acts to counteract other hormones that are associated with heart failure. BNP for CHF VMAC trial Vasodilation in the Management of Acute CHF 498 patients in a multicenter (55 US sites) trial Randomization stratified by use of right heart catheter Placebo- and nitroglycerin-controlled BNP for CHF VMAC: design 3-hour placebo-controlled period Active-controlled treatment period randomization stratification catheterized (n=246) eligible patient (n=489) noncatheterized (n=243) nitroglycerin (n=60) nitroglycerin (n=92) placebo (n=62) nesiritide fixed-dose (n=62) nesiritide fixed-dose (n=92) nesiritide adjustable-dose (n=62) nesiritide adjustable-dose (n=62) nitroglycerin (n=83) nitroglycerin (n=124) placebo (n=80) nesiritide fixed-dose (n=80) nesiritide fixed-dose (n=119) 3 hours time zero Time end of study drug 6 months BNP for CHF VMAC: findings Primary endpoint: PCWP through 3 hours NTG Nesiritide 30 29 28 27 26 25 24 23 22 21 20 19 18 # Placebo * # * # * # # * Time *p <0.05 versus placebo BNP for CHF Mortality VMAC not designed to answer mortality question No statistically significant difference at 30 day, 90 day, 150 day marks. BNP for CHF Costs Yet to be approved for general use as treatment by the FDA. Pharmacoeconomic studies have not been done. Hope to see it competitively priced with some of the inotropic agents used today. Added value possible if it aids treatment by keeping people out of ICU or out of hospital. BNP for CHF FDA approval Cardio-renal advisory panel of FDA voted 54 in January 1999 for the drug. VMAC was designed to answer some additional questions the FDA had. 3 of 4 BNP for CHF Specificity and sensitivity 100 patients presenting to the ER with signs or symptoms of congestive heart failure (eg, dyspnea, edema, weight gain) Specificity Sensitivity Jugular venous pressure 92% 34% Third heart sound 90% 26% Rales 81% 57% BNP (cutoff value of 100 pg/mL) 98% 100% Dao and colleagues, 49th Annual Scientific Session of the American College of Cardiology 2 of 4 BNP for CHF Marker for CHF BNP levels identified individuals with: normal heart function (BNP = 38 4 pg/mL) normal ejection fraction but wall motion abnormalities (BNP = 177 20 pg/mL) impaired ejection fraction (BNP = 523 50 pg/mL, p<0.001) Koon and colleagues, 49th Annual Scientific Session of the American College of Cardiology BNP for CHF The future? “I think it’s going to be an elegant way of being able to track patients with heart failure and seeing where exactly they are. It may become, if my hunch is right […] the complete blood count measurement to see where a patient is at with this heart failure syndrome at any given time.” Dr James Young Head, Section of Heart Failure and Cardiac Transplant Medicine Cleveland Clinic Foundation Cleveland, OH