Health status and effects of spironolactone in people at high risk of heart failure: The Heart OMics in AGEing (HOMAGE) randomized trial

INTRODUCTION AND OBJECTIVES: Maintaining or improving quality of life (QoL) is an important therapeutic goal. QoL may be impaired before clinical onset of heart failure (HF). This study aims to describe changes in health status and the effect of spironolactone in people at risk of developing HF. METHODS: The Heart 'OMics' in AGEing (HOMAGE) trial randomized participants to spironolactone or usual care over a maximum follow-up of 9 months. Health status was assessed as a post-hoc secondary outcome using EQ-5D-3L (and derived EQ index), EQ-VAS and HOMAGE patient-reported symptom questionnaire. RESULTS: Health status was available on 98% of the 527 trial participants. The median age was 73 years, 25% were women. The EQ index ranged from 0.18 to 1; 42% of participants had an index of 1 (best possible health status). Participants with poorer health status (EQ index <1) were predominantly women, had obesity, exertional breathlessness and lived alone. Independent baseline associations of deteriorating health status included: breathlessness on moderate exertion, smoking, higher serum galectin-3, higher E/e' and higher left ventricular mass index at baseline. Left ventricular systolic function was associated with worse baseline QoL, but not with changes in EQ index or EQ-VAS during follow-up. Spironolactone did not influence health status during follow-up. CONCLUSIONS: In people at risk of developing HF, obesity was associated with poorer health status. Worsening health status was more likely in patients with exertional breathlessness, echocardiographic signs of raised left ventricular filling pressures, and elevated galectin-3 levels at baseline. Spironolactone did not influence health status.