Assessing the impact of heart failure therapeutics on quality of life and functional capacity.

Chronic heart failure (CHF) is an increasingly common disorder with major impact on morbidity and mortality. Goals of therapy include improving survival, attenuating progression of disease, improving functional capacity, and improving health-related quality of life (HRQL). Although there are multiple HRQL instruments that are psychometrically valid, concerns exist on the ability to reliably measure HRQL concepts. Nevertheless, there has been an emphasis on improving HRQL and thus novel therapies and clinical trials have included HRQL assessment routinely. Nonpharmacologic interventions have made a greater impact on HRQL, including the use of transcutaneous aortic valve replacement, left ventricular assist devices, and cardiac resynchronization devices. Pharmacologic therapies have resulted in modest improvements in HRQL and these improvements are often not clinically meaningful to the patient and not lasting beyond 6 months. As novel therapies are developed for CHF patients, researchers must: (a) identify mechanisms that may meaningfully improve HRQL, (b) develop better instruments to measure HRQL, and (c) target the right population with enough impairment in their sense of well-being to enable an intervention to work. The recent publication of the Food and Drug Administration Draft Guidance for Use of Patient-Reported Outcome measures in clinical trials has served as the foundation for more robust trial design using these HRQL measures.