Rationale and design of the EPCHF trial: the early palliative care in heart failure trial (EPCHF)

Marc Ulrich Becher,Thomas Standl,Lukas Radbruch,Mahmoud Balata,Martin Neukirchen,Georg Nickenig,Fabian Draht,Ralf Westenfeld,Roman Pfister,Christian Zachoval,Birgitta Weltermann,Michaela Hesse

doi:10.1007/s00392-021-01903-1

Abstract

The progressive nature of heart failure (HF) coupled with high mortality and poor quality-of-life (QoL) mandates greater attention to palliative care (PC) as a routine component of HF management. Limited evidence exists from randomized controlled trials supporting the use of interdisciplinary palliative care in the progressive course of HF. The early palliative care in heart failure trial (EPCHF) is a prospective, controlled, nonblinded, multicenter study of an interdisciplinary palliative care intervention in 200 patients with symptomatic HF characterized by NYHA ≥ 2. The 12-month EPCHF intervention includes monthly consultations by a palliative care team focusing on physical and psychosocial symptom relief, attention to spiritual concerns and advance care planning. The primary endpoint is evaluated by health-related QoL questionnaires after 12 months of treatment. First the functional assessment of chronic illness therapy palliative care (FACIT-Pal) score evaluating QoL living with a chronic disease and second the Kansas City cardiomyopathy questionnaire (KCCQ) measuring QoL living with heart failure will be determined. Secondary endpoints are changes in anxiety/depression (HADS), symptom burden score (MIDOS), spiritual well-being functional assessment of chronic illness therapy spiritual well-being scale (FACIT-Sp), medical resource and cost assessment. EPCHF will help evaluate the efficacy and cost-effectiveness of palliative care in symptomatic HF using a patient-centered outcome as well as clinical and economic endpoints. EPCHF is funded by the Bundesministerium für Bildung und Forschung (BMBF, 01GY17).

Highlights

Background and rationaleThe epidemiological burden of heart failure (HF) is tremendous, with an estimated 26 million people affected worldwide [1]
The goal of the current study is to examine the effect of early integration of palliative care (PC) within standard cardiac care on QoL, reported cardiac outcomes, and the use of health services among HF patients
The functional assessment of chronic illness therapy palliative care (FACIT-Pal) score evaluating QoL living with a chronic disease and second the Kansas City Cardiomyopathy Questionnaire (KCCQ) measuring QoL living with heart failure will be determined

Summary

Introduction

The epidemiological burden of heart failure (HF) is tremendous, with an estimated 26 million people affected worldwide [1]. HF currently affects over 2 million patients in Germany. HF was the most common cause of disease-related hospitalization, the second leading cause of hospital stay, and the leading cause of in-hospital deaths in Germany in 2013 [1]. HF is a debilitating syndrome that results in a high burden of symptoms and poor QoL. Selected HF patients are candidates for aggressive treatments, such as cardiac transplantation or mechanical circulatory support; the application of these therapies to the broader HF population is limited by constrained resources [4]. The progressive nature of HF coupled with high mortality rates and poor QoL mandates greater attention to palliative care (PC) as a routine component of HF management [5]

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Conclusion