Title: Effects of point of care serial NT-proBNP measurement in patients with acute decompensated heart failure as a therapy-monitoring during hospitalization (POC-HF): Study protocol and preliminary results of a prospective, unblinded, randomized, controlled pilot trial

Abstract

Despite important advances in diagnosis and medical therapy of heart failure (HF), disease monitoring and therapy guidance remains based on clinical signs and symptoms. NT- proBNP was demonstrated to be a strong and independent predictor of morbidity and mortality in patients with HF. Only few and conflicting data are available on the efficacy of serial measurement of NT-proBNP as a tool for treatment monitoring in HF. While these are limited to the outpatient setting, no data are available on the effects in patients hospitalized for acute decompensated HF (ADHF). The goal of POC-HF was to explore whether the availability of serial NT-proBNP measurements influences treatment decisions in patients with ADHF, and whether this leads to more rapid dose adjustments of prognostically beneficial medical therapies and earlier hospital discharge. In the intervention group, serial NT-proBNP measurements every second business day were performed and made available to the treating physician, while no measurements were available in the control group. Though participating physicians were told to follow the European Society of Cardiology guidelines for the diagnosis and therapy of acute and chronic HF, individual HF therapy decisions were left at the discretion of the treating physician. Primary endpoints were defined as the effects of monitoring NT-proBNP on medical HF therapy, including type and dosing of medical therapies, rapidity of adjustments, length of hospital stay, and changes in NT-proBNP values. Secondary endpoints included the incidence of electrolyte imbalances, renal failure, changes in NYHA functional class, vital signs, body weight, quality of life, incidence of adverse events, transfer to Intensive Care Units, and mortality. Preliminary results from 26 patients are available demonstrating a trend towards more rapid and pronounced reduction of NT-proBNP values, better recovery rates from signs and symptoms of acute decompensated HF, and a faster up-titration of prognostically relevant HF therapies.