COMPASS-HF (Chronicle® offers management to patients with advanced signs and symptoms of heart failure) study design

Abstract

Introduction: The accuracy of monitoring continuous intracardiac pressures in an investigational implantable hemodynamic monitor (IHM) (Chronicle®, Medtronic, Inc.) has been previously demonstrated. A recent longitudinal case study demonstrated a 50% reduction in heart failure hospitalizations (HFH) after the start of care based on IHM data (Chronicle Guided Care, CGC) in patients (pts) with heart failure (HF). Methods: COMPASS-HF is a prospective, multi-center, randomized, single-blind parallel controlled study in pts with moderate-to-advanced HF. It evaluates the impact of CGC on safety, HFH, emergency department (ED) visits, and urgent HF clinic visits in pts randomized to standard medical therapy (SMT) complemented by CGC versus SMT alone. Two hundred seventy four NYHA Class III-IV pts with a prior HFH/ED visit will be implanted and randomized (stratified by LVEF ≤ or>50%) to CGC, where clinicians can view IHM information, or SMT where IHM data cannot be viewed for 6 months. Carefully scripted calls are made at intervals to all pts, who are blinded to their randomization, and send IHM data via a home-based remote monitor, at a minimum of once per week. Therapy is guided by algorithms developed from previous IHM experience for hypervolemia and hypovolemia with a goal of individualized “optivolemia.” Secondary study endpoints include health resource utilization, quality of life, days alive out of the hospital, and submaximal exercise capacity. Status: Over 120 pts have been enrolled in COMPASS-HF, with average duration of HF of almost 5 years. (see Table).COMPASS-HF Demographics (n=120)Mean age (yrs)58±14Male gender (%)60NYHA Class III (%)87Yrs diagnosed with HF4.9±4.0Mean HF-hospital visits 6 mths prior to enrollment1.6±1.1HF with preserved LVEF (%)25Pts with concomitant devices (%)33