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Taking people in ChinaPhase 3

Tests vicadrostat with empagliflozin in people with heart failure and weak heart pumping

Tests vicadrostat plus empagliflozin against placebo in adults with reduced-pumping heart failure.

Plain-language title generated from the registry record
Registry title: A Study to Test Whether Vicadrostat (BI 690517) in Combination With Empagliflozin Helps People With Heart Failure and a Weak Pumping Function of the Left Side of the Heart

Key facts

Where
Beijing, Changchun, Changde, Changsha, Chengdu, Chenzhou, Chongqing, Dalian, Daqing, Foshan, Fuzhou, Guangzhou, Guiyang, Haikou, Harbin, Jiangmen, Jinan, Lanzhou, Linfen, Luoyang, Nanchang, Nanjing, Nanning, Nanyang, Ningbo, Pingxiang, Shanghai, Shenyang, Shenzhen, Shijiazhuang, Tai’an, Taiyuan, Tianjin, Wuhan, Xi'an, Xinxiang, Xuancheng, Xuzhou, Yinchuan, Yueyang, Yuncheng, Zhangjiakou, Zhengzhou, and Zhenjiang, ChinaSee the 64 sites
Phase
Phase 3

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with long-lasting heart failure and a weak pumping function of the left side of the heart (LVEF below 40%). It tests vicadrostat with empagliflozin against placebo with empagliflozin.

Age
18 years or older
Sex
Men and women can join. Women who can become pregnant must use highly effective birth control.
Disease stage
Chronic heart failure diagnosed at least 3 months before the first visit, in NYHA classes II to IV, with LVEF < 40%.
Earlier treatment
Must be on standard heart failure care set by guidelines and the doctor, not counting SGLT2 inhibitors and MRAs. No MRA or potassium-sparing diuretic in the 14 days before the first visit.
Biomarker or test result
Raised NT-proBNP at the first visit, measured at the central laboratory.

Main reasons for not taking part

  • Heart attack, stroke, TIA, bypass or valve surgery, or other major surgery in the 90 days before Visit 2
  • Heart transplant, waiting for one, or an implanted left ventricular assist device
  • Certain heart muscle diseases, such as amyloidosis, hypertrophic obstructive cardiomyopathy or peripartum cardiomyopathy
  • Acute myocarditis in the 90 days before the first visit
  • Treatment with a direct renin inhibitor, other aldosterone synthase inhibitors or fludrocortisone

Read by machine on 12 November 2026.

Where in China

  • Beijing Anzhen Hospital, Capital Medical UniversityBeijing, ChinaContact: Boehringer IngelheimTaking people
  • Cardiovascular Institute and Fu Wai HospitalBeijing, ChinaContact: Boehringer IngelheimTaking people
  • China-Japan Union Hospital of JiLin UniversityChangchun, ChinaContact: Boehringer IngelheimTaking people
  • Jilin Province People's HospitalChangchun, ChinaContact: Boehringer IngelheimTaking people
  • The First Hospital of Jilin UniversityChangchun, ChinaContact: Boehringer IngelheimTaking people
  • Changde Second People's HospitalChangde, ChinaContact: Boehringer IngelheimTaking people
  • Hunan Provincial People's HospitalChangsha, ChinaContact: Boehringer IngelheimTaking people
  • The Second Xiangya Hospital of Central South UniversityChangsha, ChinaContact: Boehringer IngelheimTaking people
  • The Third Hospital of ChangshaChangsha, ChinaContact: Boehringer IngelheimTaking people
  • Sichuan Provincial People's HospitalChengdu, ChinaContact: Boehringer IngelheimTaking people
  • Chenzhou No.1 People's HospitalChenzhou, ChinaContact: Boehringer IngelheimTaking people
  • Chongqing Three Gorges Central HospitalChongqing, ChinaContact: Boehringer IngelheimTaking people
  • Second Affiliated Hospital Chongqing Medical UniversityChongqing, ChinaContact: Boehringer IngelheimTaking people
  • Affiliated Zhongshan Hospital of Dalian UniversityDalian, ChinaContact: Boehringer IngelheimTaking people
  • Daqingshi People's HospitalDaqing, ChinaContact: Boehringer IngelheimTaking people
  • The First People's Hospital of FoshanFoshan, ChinaContact: Boehringer IngelheimTaking people
  • The First Affiliated Hospital of Fujian Medical UniversityFuzhou, ChinaContact: Boehringer IngelheimTaking people
  • Guangdong Provincial People's HospitalGuangzhou, ChinaContact: Boehringer IngelheimTaking people
  • The Affiliated Panyu Central Hospital of Guangzhou Medical UniversityGuangzhou, ChinaContact: Boehringer IngelheimTaking people
  • The First Affiliated Hospital of Guangzhou University of Chinese MedicineGuangzhou, ChinaContact: Boehringer IngelheimTaking people
  • Third Affiliated Hospital of Guangzhou Medical UniversityGuangzhou, ChinaContact: Boehringer IngelheimTaking people
  • Guizhou Provincial People's HospitalGuiyang, ChinaContact: Boehringer IngelheimTaking people
  • Hainan General HospitalHaikou, ChinaContact: Boehringer IngelheimTaking people
  • The First Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaContact: Boehringer IngelheimTaking people
  • Jiangmen Central HospitalJiangmen, ChinaContact: Boehringer IngelheimTaking people
  • Center Hospital of JinanJinan, ChinaContact: Boehringer IngelheimTaking people
  • Lanzhou University Second HospitalLanzhou, ChinaContact: Boehringer IngelheimTaking people
  • Linfen Central HospitalLinfen, ChinaContact: Boehringer IngelheimTaking people
  • Luoyang First People's HospitalLuoyang, ChinaContact: Boehringer IngelheimTaking people
  • The First Affiliated Hospital of Henan University of Science and TechnologyLuoyang, ChinaContact: Boehringer IngelheimTaking people
  • Jiangxi Province Integrated Tractional Chinese Medicine& Western Medicine HospitalNanchang, ChinaContact: Boehringer IngelheimTaking people
  • The First Affiliated Hospital of NanChang UniversityNanchang, ChinaContact: Boehringer IngelheimTaking people
  • Nanjing Jiangning HospitalNanjing, ChinaContact: Boehringer IngelheimTaking people
  • Zhongda Hospital Southeast UniversityNanjing, ChinaContact: Boehringer IngelheimTaking people
  • The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaContact: Boehringer IngelheimTaking people
  • Nanyang First People's HospitalNanyang, ChinaContact: Boehringer IngelheimTaking people
  • Nanyang Second General HospitalNanyang, ChinaContact: Boehringer IngelheimTaking people
  • Ningbo Second HospitalNingbo, ChinaContact: Boehringer IngelheimTaking people
  • The First Affiliated Hospital of Ningbo UniversityNingbo, ChinaContact: Boehringer IngelheimTaking people
  • Pingxiang People's HospitalPingxiang, ChinaContact: Boehringer IngelheimTaking people
  • Shanghai General HospitalShanghai, ChinaContact: Boehringer IngelheimTaking people
  • Tongren Hospital Shanghai Jiaotong University School of MedicineShanghai, ChinaContact: Boehringer IngelheimTaking people
  • Zhongshan Hospital Affiliated to Fudan UniversityShanghai, ChinaContact: Boehringer IngelheimTaking people
  • People's Hospital of Liaoning ProvinceShenyang, ChinaContact: Boehringer IngelheimTaking people
  • Shengjing Hospital Of China Medical UniversityShenyang, ChinaContact: Boehringer IngelheimTaking people
  • Shenzhen People's HospitalShenzhen, ChinaContact: Boehringer IngelheimTaking people
  • The Second Hospital of Hebei Medical UniversityShijiazhuang, ChinaContact: Boehringer IngelheimTaking people
  • Taian City Central HospitalTai’an, ChinaContact: Boehringer IngelheimTaking people
  • Shanxi Bethune HospitalTaiyuan, ChinaContact: Boehringer IngelheimTaking people
  • Shanxi Cardiovascular HospitalTaiyuan, ChinaContact: Boehringer IngelheimTaking people
  • The 2nd Hospital of Tianjin Medical UniversityTianjin, ChinaContact: Boehringer IngelheimTaking people
  • Tianjin Union Medical Center (Nankai University Affiliated Hospital)Tianjin, ChinaContact: Boehringer IngelheimTaking people
  • Hubei Province Zhongshan HospitalWuhan, ChinaContact: Boehringer IngelheimTaking people
  • Renmin Hospital of Wuhan UniversityWuhan, ChinaContact: Boehringer IngelheimTaking people
  • Shaanxi provincial people's hospitalXi'an, ChinaContact: Boehringer IngelheimTaking people
  • Xinxiang Central HospitalXinxiang, ChinaContact: Boehringer IngelheimTaking people
  • The People's Hospital Of Xuancheng CityXuancheng, ChinaContact: Boehringer IngelheimTaking people
  • The General Hospital of XZCMG (The Second Affiliated Hospital of Xuzhou Medical University)Xuzhou, ChinaContact: Boehringer IngelheimTaking people
  • The first People's Hosptal of YinchuanYinchuan, ChinaContact: Boehringer IngelheimTaking people
  • Yueyang Central HospitalYueyang, ChinaContact: Boehringer IngelheimTaking people
  • Yuncheng Central HospitalYuncheng, ChinaContact: Boehringer IngelheimTaking people
  • The First Affiliated Hospital of Hebei North UniversityZhangjiakou, ChinaContact: Boehringer IngelheimTaking people
  • The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaContact: Boehringer IngelheimTaking people
  • Affiliated Hospital of Jiangsu UniversityZhenjiang, ChinaContact: Boehringer IngelheimTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Boehringer Ingelheim
Trial code
NCT06935370EU 2024-519525-38-00
Record updated
12 November 2026
Original description
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.Read full original descriptionShow less

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%

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.

Inclusion: At least 18 years old and at least at the legal age of consent in countries where it is greater than 18 years; Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial; Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the protocol; Chronic heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) classes II to IV at Visit 1, with left ventricular ejection fraction (LVEF) < 40% per local reading (obtained by echocardiography, radionuclide ventriculography, invasive angiography, magnetic resonance imaging (MRI), or computed tomography (CT)); Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory; Treated according to best possible standard of care (SOC) (disregarding sodium-dependent glucose co-transporter 2 inhibitor (SGLT2i) and mineralocorticoid receptor antagonist (MRA)) in accordance with applicable heart failure (HF) local/international guidelines and judgement of the investigator; Additional inclusion criteria apply.

Exclusion: Treatment with an MRA (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with an MRA should not be discontinued with the intention of study enrolment; 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 receptor-neprilysin inhibitor (ARNi) used simultaneously at Visit 2; 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; In case of acute decompensated HF:; i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation; i.v. diuretic with a dose that has been increased/intensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary); Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft surgery (CABG), heart valve surgery/intervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, CABG); Percutaneous coronary intervention (PCI) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2; Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within 12 months prior to Visit 1 and until Visit 2; Acute inflammatory heart disease, such as acute myocarditis, within 90 days preceding prior to Visit 1 and until Visit 2 Further exclusion criteria apply; Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD); Treatment with amiloride or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator.

ClinicalTrials.gov NCT06935370 · EU CTIS 2024-519525-38-00