Clinical Trials: Methods and Design Investigating Pain in Heart Failure Patients: Rationale and Design of the Pain Assessment, Incidence & Nature in Heart Failure (PAIN-HF) Study

Background: Heart failure is a major cause of morbidity and mortality and is increasing in prevalence. Treatments for heart failure permit a growing number of persons to live with the illness for many years. The burden of symptoms in persons with advanced heart failure is high. Fatigue, limited exertion, dyspnea, and depression are commonly associated with heart failure, but pain is common as well. Methods and Results: Although it is known that underlying comorbidities modify the response to and experience of pain, the interaction between pain and the clinical syndrome of heart failure has not been studied to date. The Pain Assessment, Incidence & Nature in Heart Failure (PAIN-HF) study will evaluate pain in patients with advanced heart failure. Specifically, PAIN-HF will examine the anatomical location of pain, prevalence of pain, its association with aspects of patients’ heart failure and comorbid conditions, and its relation to interventions and medications to treat pain. Conclusions: This study to identify the nature, incidence, and character of pain is an important step in relieving distress and discomfort in persons with heart failure. (J Cardiac Fail 2008;14:276e282)