At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- vicadrostat (drug), empagliflozin (drug), Placebo (drug)
- How long the study runs
- Study runs about 45 months (dates as stated)
- About the drug or intervention
- vicadrostat — drug: vicadrostat · empagliflozin — drug: empagliflozin · Placebo — drug: Placebo matching vicadrostat
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 4,200
- Started
- 2025-05-20
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for heart failure
- • Phase3 - 4,200 participants
- • This study is open to adults with chronic heart failure (HF) who have a reduced left ventricular ejection fraction (LVEF) of less than 40%
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with heart failure
Where?
- • Bristol - Southmead Hospital
- • Clydebank - Golden Jubilee National Hospital
- • Exeter - Royal Devon and Exeter Hospital, Wonford
- • Halifax - Calderdale Royal Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years
- ✓Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory
- ✓Additional inclusion criteria apply.
Who cannot take part
- ✗Receiving the following treatments:
- ✗A direct renin inhibitor (e.g. aliskiren) at Visit 2
- ✗More than one angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin...
- ✗Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
- ✗Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2
See the full criteria
Where Is This Study? (6 UK sites)
Southmead Hospital
Bristol BS10 5NB, United Kingdom
Golden Jubilee National Hospital
Clydebank G81 4DY, United Kingdom
Royal Devon and Exeter Hospital, Wonford
Exeter EX2 5DW, United Kingdom
Calderdale Royal Hospital
Halifax HX3 0PW, United Kingdom
Northwick Park Hospital
Harrow HA1 3UJ, United Kingdom
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
How to Get in Touch
Boehringer Ingelheim
Sponsor contactCONTACT
