Effects of spironolactone on serum markers of fibrosis in people at high risk of developing heart failure:rationale, design and baseline characteristics of a proof-of-concept, randomised, precision-medicine, prevention trial. The Heart OMics in AGing (HOMAGE) trial

AimsAsymptomatic patients with coronary artery disease (CAD), hypertension and/or type 2 diabetes mellitus (T2DM) are at greater risk of developing heart failure (HF). Fibrosis, leading to myocardial and vascular dysfunction, might be an important pathway of progression. The Heart OMics in AGing (HOMAGE) trial aims to investigate the effects of spironolactone on serum markers of collagen metabolism and on cardiovascular structure and function in people at risk of developing HF and potential interactions with a marker of fibrogenic activity, galectin-3.Methods and resultsThe HOMAGE trial is a prospective, randomised, open-label, blinded endpoint (PROBE) study comparing spironolactone (up to 50mg/day) and standard care over 9months in people with clinical risk factors for developing HF, including hypertension, CAD and T2DM, and elevated plasma concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP, 125 to 1000ng/L) or B-type natriuretic peptide (BNP, 35 to 280ng/L). Exclusion criteria included left ventricular ejection fractionConclusionsThe HOMAGE trial will provide insights on the effect of spironolactone on pathways that might drive progression to HF. Clinical Trial Registration: ClinicalTrials.gov NCT02556450.