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 47 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
- 6,712
- Started
- 2024-06-17
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for heart failure
- • Phase3 - 6,712 participants
- • This study is open to adults aged 18 or above legal age with heart failure
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with heart failure
Where?
- • Barnet - Barnet Hospital
- • Bristol - Southmead Hospital
- • Exeter - Royal Devon and Exeter Hospital, Wonford
- • Halifax - Calderdale Royal Hospital
- • +6 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 aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.
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 of the legal age of consent in countries where it is greater than 18 years
- ✓Signed and dated written agreement to take part in accordance with ICH-GCP and local legislation prior to admission to the...
- ✓Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:
- ✓in participants with BMI ≥27 kg/m² to \<35 kg/m²: ≥220 pg/mL for participants without Afib or Aflutter (at Visit 1...
- ✓in participants with BMI ≥35 kg/m²: ≥125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375...
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...
- ✗In case of acute decompensated HF:
- ✗i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose...
See the full criteria
Where Is This Study? (10 UK sites)
Barnet Hospital
Barnet EN5 3DJ, United Kingdom
Southmead Hospital
Bristol BS10 5NB, United Kingdom
Royal Devon and Exeter Hospital, Wonford
Exeter EX2 5DW, United Kingdom
Calderdale Royal Hospital
Halifax HX3 0PW, United Kingdom
Wycombe Hospital
High Wycombe HP11 2TT, United Kingdom
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
The Royal Oldham Hospital
Oldham OL1 2JH, United Kingdom
Northern General Hospital
Sheffield S5 7AU, United Kingdom
Royal Cornwall Hospital
Truro TR1 3LJ, United Kingdom
York Hospital
York YO31 8HE, United Kingdom
How to Get in Touch
Boehringer Ingelheim
Sponsor contactCONTACT
