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Taking people in ChinaPhase 3

Tests vicadrostat with empagliflozin in people with heart failure

Tests vicadrostat taken with empagliflozin against placebo in adults with heart failure.

Key facts

Who runs it
Boehringer Ingelheim
Where
Baotou, Beijing, Changchun, Changde, Changsha, Chengdu, Chenzhou, Dalian, Daqing, Deyang, Foshan, Fuzhou, Guangzhou, Guiyang, Haikou, Hangzhou, Harbin, Huainan, Jiangmen, Jinan, Jining, Lanzhou, Linfen, Luoyang, Nanchang, Nanjing, Nanning, Nanyang, Panjin, Pingxiang, Shanghai, Shengyang, Shenzhen, Shijiazhuang, Tianjin, Wenzhou, Wuhan, Xi'an, Xiangtan, Xinxiang, Xuancheng, Xuzhou, Yanji, Yinchuan, Yueyang, Yuncheng, Zhangjiakou, Zhengzhou, and Zhenjiang, ChinaSee the 75 sitesAlso in 29 other countries, 583 sites
Trial code
Registry title
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure
Status
Recruiting
Phase
Phase 3
People taking part
6,712 people, planned
Started
17 Jun 2024
Expected to end
22 May 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • vicadrostat
  • empagliflozin
  • placebo
Record updated
12 November 2026

Who can take part

AI summary

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 who have symptoms and a left ventricular ejection fraction of 40% or more, plus signs of structural heart change.

Age
18 years or older, and at least the legal age of consent where that is higher than 18.
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, NYHA class II-IV, left ventricular ejection fraction of 40% or more, with a structural heart abnormality and raised NT-proBNP.
Earlier treatment
Must be treated with standard heart failure care set by guidelines (not counting SGLT2 inhibitors and MRAs). Must not have taken an MRA or a potassium-sparing diuretic in the 14 days before the first visit.
Biomarker or test result
Raised NT-proBNP at the central laboratory; the cut-off depends on body mass index and on atrial fibrillation or flutter. One further sign is also needed, such as diuretic treatment, a recent hospital stay for heart failure, higher NT-proBNP, or UACR of 30 mg/g or more.

Main reasons for not taking part

  • Treatment with an MRA or a potassium-sparing diuretic such as amiloride
  • Heart attack, stroke, TIA or major heart surgery in the 90 days before Visit 2
  • Heart transplant, waiting for one, or an implanted left ventricular assist device
  • Heart muscle disease such as amyloidosis or hypertrophic cardiomyopathy
  • Severe known valve disease or acute myocarditis in the 90 days before the first visit

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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 informed consent in accordance with 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 International Conference on Harmonisation (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 participant information
  • Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2
  • Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2
  • Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:; in participants with body mass index (BMI) <27 kg/m²: ≥300 pg/mL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG); in participants with BMI ≥27 kg/m² to <35 kg/m²: ≥220 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG); in participants with BMI ≥35 kg/m²: ≥125 pg/mL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg/mL for participants with Afib or Aflutter (at Visit 1 ECG)
  • At least one of the following:; Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1; Documented hospitalisation for HF within 6 months prior to Visit 1; Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1; in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg/mL; for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL; Urine albumin-to-creatinine ratio (UACR) ≥30 mg/g, analysed at the central laboratory at Visit 1
  • Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local/international guidelines and judgment of the investigator Further inclusion criteria apply

Who cannot take part

  • Treatment with an mineralocorticoid receptor antagonist (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 MRA should not be interrupted with the intention of enrolment into the study
  • 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; 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 (Visit 2); 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); Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2; Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial
  • Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, 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, coronary artery bypass graft surgery/CABG)
  • Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) 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 genetic hypertrophic cardiomyopathy,known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2
  • Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2
  • Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)
  • Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study Further exclusion criteria apply
  • 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

Where in China

Also in 29 other countries, 583 sites

  • Baotou Central HospitalBaotou, ChinaContact: Boehringer IngelheimTaking people
  • The First Affiliated Hospital of Baotou Medical CollegeBaotou, ChinaContact: Boehringer IngelheimTaking people
  • Beijing Anzhen Hospital, Capital Medical UniversityBeijing, ChinaContact: Boehringer IngelheimTaking people
  • Cardiovascular Institute and Fu Wai HospitalBeijing, ChinaContact: Boehringer IngelheimTaking people
  • Peking University Third 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
  • Changsha Central 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
  • The Third Xiangya Hospital of Central South UniversityChangsha, ChinaContact: Boehringer IngelheimTaking people
  • Chengdu Second People's HospitalChengdu, ChinaContact: Boehringer IngelheimTaking people
  • The First Affiliated Hospital of Chengdu Medical CollegeChengdu, ChinaContact: Boehringer IngelheimTaking people
  • West China Hospital，Sichuan UniversityChengdu, ChinaContact: Boehringer IngelheimTaking people
  • Chenzhou No.1 People's HospitalChenzhou, ChinaContact: Boehringer IngelheimTaking people
  • Affiliated Zhongshan Hospital of Dalian UniversityDalian, ChinaContact: Boehringer IngelheimTaking people
  • Daqing Oilfield General HospitalDaqing, ChinaContact: Boehringer IngelheimTaking people
  • Daqingshi People's HospitalDaqing, ChinaContact: Boehringer IngelheimTaking people
  • Deyang People's HospitalDeyang, ChinaContact: Boehringer IngelheimTaking people
  • The First People's Hospital of FoshanFoshan, ChinaContact: Boehringer IngelheimTaking people
  • No.900 Hospital of PLA Joint Logistics Support ForceFuzhou, ChinaContact: Boehringer IngelheimNot yet recruiting
  • The First Affiliated Hospital of Fujian Medical UniversityFuzhou, ChinaContact: Boehringer IngelheimTaking people
  • Guangdong Provincial People's HospitalGuangzhou, ChinaContact: Boehringer IngelheimTaking people
  • Sun yet-sen Memorial Hospital, Sun yet-sen UnivesityGuangzhou, 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
  • The Affiliated Hospital of Guizhou Medical UniversityGuiyang, ChinaContact: Boehringer IngelheimTaking people
  • Hainan General HospitalHaikou, ChinaContact: Boehringer IngelheimTaking people
  • Hangzhou First People's HospitalHangzhou, ChinaContact: Boehringer IngelheimTaking people
  • The First Affiliated Hospital of Harbin Medical UniversityHarbin, ChinaContact: Boehringer IngelheimTaking people
  • Huainan First People's HospitalHuainan, ChinaContact: Boehringer IngelheimTaking people
  • Jiangmen Central HospitalJiangmen, ChinaContact: Boehringer IngelheimTaking people
  • Center Hospital of JinanJinan, ChinaContact: Boehringer IngelheimTaking people
  • Jining No. 1 People's Hospital.Jining, ChinaContact: Boehringer IngelheimTaking people
  • Lanzhou University Second HospitalLanzhou, ChinaContact: Boehringer IngelheimTaking people
  • Linfen Central HospitalLinfen, ChinaContact: Boehringer IngelheimTaking people
  • Luoyang Third 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
  • Nanchang People's HospitalNanchang, ChinaContact: Boehringer IngelheimTaking people
  • The First Affiliated Hospital of NanChang UniversityNanchang, ChinaContact: Boehringer IngelheimTaking people
  • Nanjing Drum Tower hospitalNanjing, ChinaContact: Boehringer IngelheimTaking people
  • Nanjing Jiangning HospitalNanjing, 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
  • Panjin Liao Oil Gem Flower HospitalPanjin, 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
  • Shengjing Hospital of China Medical UniversityShengyang, ChinaContact: Boehringer IngelheimTaking people
  • Shenzhen People's HospitalShenzhen, ChinaContact: Boehringer IngelheimTaking people
  • The Second Hospital of Hebei Medical UniversityShijiazhuang, ChinaContact: Boehringer IngelheimTaking people
  • Tianjin Union Medical Center (Nankai University Affiliated Hospital)Tianjin, ChinaContact: Boehringer IngelheimTaking people
  • Wenzhou People's HospitalWenzhou, ChinaContact: Boehringer IngelheimTaking people
  • Hubei Province Zhongshan HospitalWuhan, ChinaContact: Boehringer IngelheimTaking people
  • Renmin Hospital of Wuhan UniversityWuhan, ChinaContact: Boehringer IngelheimTaking people
  • Wuhan Puai HospitalWuhan, ChinaContact: Boehringer IngelheimTaking people
  • Shaanxi provincial people's hospitalXi'an, ChinaContact: Boehringer IngelheimTaking people
  • Xiangtan Central HospitalXiangtan, ChinaContact: Boehringer IngelheimTaking people
  • The Third Affiliated Hospital of Xinxiang Medical UniversityXinxiang, 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
  • Yanbian University HospitalYanji, 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

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • vicadrostat/empagliflozinTreatment being tested

    Treatment: vicadrostat and empagliflozin

  • placebo/empagliflozinPlacebo, for comparison

    Treatment: empagliflozin and placebo

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

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
EASi-HF Preserved - 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 Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) ≥40%
Plain-language title
Tests vicadrostat with empagliflozin in people with heart failureGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
12 November 2026