Palliative Care in Heart Failure: Results of a Randomized, Controlled Clinical Trial

Abstract

Background: Despite medical advances and robust data for guideline-directed medical therapy (GDMT), heart failure (HF) remains a progressive disease associated with significant physical and psychosocial morbidity and high mortality. Palliative care approaches, effectively used in other chronic illnesses, are in early stage evaluation and validation in the HF population. Methods: The Palliative Care in Heart Failure Trial (PAL-HF) was an NIH-funded, single-center, randomized, controlled clinical trial of a patient-centered, multidisciplinary intervention targeted in HF patients at high risk for 6-month hospitalization and mortality. The nurse practitioner-delivered intervention focused on relieving physical and psychosocial symptoms, addressing spiritual concerns and advanced care planning. The primary end-point was health-related quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Palliative Care Subscale of the Functional Assessment of Chronic Illness Therapy (FACIT-PAL) at 6 months. Secondary endpoints include changes in depression, anxiety, spiritual well-being, caregiver satisfaction, resource utilization and a composite of death, HF hospitalization and quality of life. Results: Overall, 150 patients were randomized to GDMT or GDMT+ palliative care intervention (75 patients per study arm). The mean age was 71 years, 47% were women and 41% were African-American. The mean HF duration was 66.9 months and there was an average of 2.2 hospitalizations in the 12 months prior to enrollment. 45% of the patients had an ejection fraction >40% and the mean baseline NT-pro-BNP was 11,576 pmol/L. Most participants (82%) were sedentary >50% of the time, and 85% rated their overall health as poor/fair. The trial was successful on meeting the primary endpoint. Results including primary endpoint and key secondary endpoints will be presented. Conclusions: The results of PAL-HF demonstrate successful enrollment of a critically ill HF patient cohort. The addition of a palliative care intervention focused on symptom relief, spiritual well-being and advanced care planning improved domain-specific quality of life. PAL-HF should be used as pilot data for larger, multi-center clinical trials evaluating strategies to improve care in this vulnerable population.