Rationale and Design of the ESPIAL Trial - A Prospective, Randomized, Exploratory Study to Evaluate the Effect of Esaxerenone on Reduction of Urinary Albumin to Creatinine Ratio in Hypertensive Patients Concomitant With Heart Failure and Albuminuria.

Abstract

Background: Hypertension and coronary artery disease (CAD) are predominant factors of heart failure (HF). The American College of Cardiology/American Heart Association and the Japanese Circulation Society/Japanese Heart Failure Society stages of HF emphasize the development and progression of disease, and advanced stages and progression are associated with reduced survival. In patients with new-onset or worsening HF, albuminuria is consistently associated with clinical and circulating biomarkers of congestion. Esaxerenone is an oral, non-steroidal, selective mineralocorticoid receptor antagonist. It has not been elucidated whether esaxerenone reduces the urinary albumin-to-creatinine ratio (UACR) in hypertensive patients concomitant with HF and albuminuria.

Methods and results: The ESPIAL trial (jRCTs 051210066) is a multicenter, randomized, open-label, active-controlled, parallel-group, exploratory, investigator-initiated clinical study to evaluate whether esaxerenone reduces UACR in hypertensive patients concomitant with HF and albuminuria. This study enrolled hypertensive patients concomitant with HF and albuminuria. The patients were randomized to an esaxerenone group or an amlodipine group in a 1 : 1 ratio. The primary outcome was the ratio of UACR before treatment and 24 weeks after treatment.

Conclusions: The ESPIAL trial evaluates the effect of esaxerenone on reduction of UACR in hypertensive patients concomitant with HF and albuminuria.