A Registry-based Cluster Randomized Trial to Compare the Effect of Spironolactone vs. Eplerenone on Clinical Outcomes in Patients With Symptomatic Systolic Heart Failure

Launched by BISPEBJERG HOSPITAL · Jun 11, 2019

Keywords

ClinConnect Summary

This Danish study is comparing two approved heart failure medicines, spironolactone and eplerenone, to see which works better for people with systolic heart failure (when the heart pumps less effectively and the heart’s ejection fraction is below 40%). The trial is run through heart failure clinics across Denmark, and each clinic will switch between the two drugs in different time blocks. The main goal is to find out if one drug reduces the risk of death or hospital stays for heart failure over about 5–6 years, with outcomes tracked using national health records.

Who can be part? The study includes children, adults, and older adults who are registered in the Danish Heart Failure Registry, have systolic heart failure with an ejection fraction under 40%, and have a prescription for an aldosterone antagonist (spironolactone or eplerenone) at the time of registration. People who had previously used an aldosterone antagonist before registration are not eligible. If you’re eligible, you would receive one of the two drugs according to the clinic’s schedule and current guidelines. Data about outcomes are collected from Danish health records, so there may be no extra in-person visits beyond standard care. The study is enrolling by invitation and is expected to complete in 2028, with data stored securely in Denmark.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • all patients registered in the Danish Heart Failure Registry who has a baseline left ventricular ejection fraction \<40% and who has filled in a prescription for an aldosterone antagonist
• Exclusion Criteria:
• • patients who had filled in a prescription for an aldosterone antagonist prior ro registration in the Danish Heart Failure Registry