EASi-HF Reduced - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Chronic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) < 40%

Official Summary

This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%. People can join the study if they have been diagnosed with chronic HF at least 3 months before they start on the study. The purpose of this study is to find out whether a medicine called vicadrostat, in combination with another medicine called empagliflozin, helps people with chronic heart failure. In this study, participants are put into 2 groups randomly. Participants have an equal chance of being in either group. One group takes vicadrostat/empagliflozin tablets, and the other group takes placebo/empagliflozin tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants take the study medicines as tablets once a day for between about 6 months and about 3.5 years. During this time, they can continue their regular treatment for heart failure. Participants can stay in the study as long as they benefit from treatment and can tolerate it, for a maximum of about 3.5 years. During this time, they visit the study site regularly. The exact number of visits is different for each participant, depending on how long they stay in the study. The study staff may also contact the participants by phone for some visits. Participants also regularly answer questions about their well-being. The doctors document when participants experience worsening of their heart failure symptoms, go to hospital due to heart failure or die during the study. The time until these events are observed is compared between the two treatment groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 4,200 participants

Interventions

• DRUG: vicadrostat — vicadrostat
• DRUG: empagliflozin — empagliflozin
• DRUG: Placebo — Placebo matching vicadrostat

Primary Outcomes

• Time to first event of Cardiovascular (CV) death, or Hospitalisation for heart failure (HHF), or Urgent heart failure (HF) visit (up to 43 months)

Secondary Outcomes

• Key secondary endpoint: Time to first event of cardiovascular death or HHF (up to 43 months)
• Key secondary endpoint: Occurrences of HHF (first and recurrent) (up to 43 months)
• Key secondary endpoint: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) at Week 32 (at baseline, at week 32)
• Key secondary endpoint: Time to cardiovascular death (up to 43 months)
• Key secondary endpoint: Time to all-cause mortality (up to 43 months)

Trial Locations

• Alliance for Multispecialty Research, LLC, Mobile, Alabama, United States
• Drug Research and Analysis Corporation, Montgomery, Alabama, United States
• Cure Clinical Research, Beverly Hills, California, United States
• Valley Clinical Trials, Inc., Covina, California, United States
• North Coast Cardiology, Encinitas, California, United States
• Orange County Research Center, Lake Forest, California, United States
• Merced Vein and Vascular Center, Merced, California, United States
• Radin Cardiovascular Medical Group, Newport Beach, California, United States
• Amicis Research Center - Nordhoff, Northridge, California, United States
• University of California San Diego, San Diego, California, United States
• ...and 10 more locations

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