Clinical Trials List
Protocol Number1378-0018
Active
2025-05-01 - 2029-06-30
Phase III
Recruiting8
ICD-10I50.20
Unspecified systolic (congestive) heart failure
ICD-10I50.21
Acute systolic (congestive) heart failure
ICD-10I50.22
Chronic systolic (congestive) heart failure
ICD-10I50.23
Acute on chronic systolic (congestive) heart failure
ICD-10I50.30
Unspecified diastolic (congestive) heart failure
ICD-10I50.31
Acute diastolic (congestive) heart failure
ICD-10I50.32
Chronic diastolic (congestive) heart failure
ICD-10I50.33
Acute on chronic diastolic (congestive) heart failure
ICD-10I50.40
Unspecified combined systolic (congestive) and diastolic (congestive) heart failure
ICD-10I50.41
Acute combined systolic (congestive) and diastolic (congestive) heart failure
ICD-10I50.42
Chronic combined systolic (congestive) and diastolic (congestive) heart failure
ICD-10I50.43
Acute on chronic combined systolic (congestive) and diastolic (congestive) heart failure
ICD-10I50.9
Heart failure, unspecified
ICD-9428.0
Congestive heart failure
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%
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
IQVIA Holdings, Inc
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 鍾偉信 Division of Cardiovascular Diseases
- Shih-Sheng Chang Division of Cardiovascular Diseases
- 林晏年 Division of Cardiovascular Diseases
- 陳恬恩 Division of Cardiovascular Diseases
- 王宇澄 Division of Cardiovascular Diseases
- Lien-Cheng Hsiao Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wen-Chung Yu Division of Cardiovascular Diseases
- 黃偉銘 Division of Cardiovascular Diseases
- 吳承學 Division of General Internal Medicine
- 蔡泉財 Division of Cardiovascular Diseases
- 李慶威
- Hao-min Cheng 教學部
- Chern-En Chiang 臨床試驗科
- 張皓智 Division of Cardiovascular Diseases
- Tse-Min Lu Division of Family Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳志維 Division of Cardiovascular Diseases
- 洪元 Division of Cardiovascular Diseases
- 陳彥舟 Division of Cardiovascular Diseases
- Chien-Yi Hsu Division of Cardiovascular Diseases
- 鄭宇倫 Division of Cardiovascular Diseases
- Yung-Ta Kao Division of Cardiovascular Diseases
- 蕭卜源 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 簡育珊 Division of Cardiovascular Diseases
- 王奇彥 Division of Cardiovascular Diseases
- 何鴻鋆 Division of Cardiovascular Diseases
- Shang-Ju Wu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 張惟智 Division of Cardiovascular Diseases
- 楊淵博 Division of Cardiovascular Diseases
- 陳美綾 Division of Cardiovascular Diseases
- 廖英傑 Division of Cardiovascular Diseases
- 王聖云 Division of Cardiovascular Diseases
- 黃宏凱 Division of Cardiovascular Diseases
- 李政良 Division of Cardiovascular Diseases
- 楊秉忠 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Tsung-Hsien Lin
Co-Principal Investigator
- 黃天祈 Division of Cardiovascular Diseases
- Wei-Chung Tsai Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
- Ye-Hsu Lu Division of Cardiovascular Diseases
- 吳韋璁 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Chronic heart failure (HF: NYHA Class II–IV) with left ventricular ejection fraction (LVEF) < 40%.
Objectives
The purpose of this clinical study is to evaluate the efficacy and safety of an investigational drug called vicadrostat (BI 690517) in combination with empagliflozin (empa) in participants diagnosed with heart failure (HF). In this study, the potential new combination therapy will be compared with empagliflozin plus placebo.
Test Drug
empagliflozin
vicadrostat (BI 690517)
vicadrostat (BI 690517)
Active Ingredient
BI 690517
Empagliflozin
Empagliflozin
Dosage Form
116
116
116
Dosage
10mg
10mg
10mg
Endpoints
Time to first occurrence of cardiovascular (CV) death, hospitalization for heart failure (HHF), or urgent heart failure (HF) visit. Events will be adjudicated by the investigator according to predefined criteria.
Inclution Criteria
Aged ≥18 years, and at or above the legal age of consent in the respective country (if higher than 18 years).
Signed and dated written informed consent prior to trial entry, in accordance with the International Conference on Harmonisation – Good Clinical Practice (ICH-GCP) and applicable local laws.
Male or female participants.
Women of childbearing potential (WOCBP) must be willing and able to use a highly effective method of contraception as defined in ICH M3(R2), i.e., one that results in a failure rate of less than 1% per year when used consistently and correctly.
Diagnosis of chronic heart failure (HF) for at least 3 months prior to Visit 1, and classified as NYHA Class II–IV at Visit 1, with a locally measured left ventricular ejection fraction (LVEF) <40%, determined by echocardiography, radionuclide ventriculography, invasive angiography, MRI, or CT.
If a previous LVEF measurement within 12 months prior to Visit 1 is available, it may be used. Alternatively, LVEF may be measured after informed consent and before randomization at Visit 2.
If multiple LVEF assessments exist, the most recent value should be used.
Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) at Visit 1, measured at the central laboratory, defined as:
a. For participants without atrial fibrillation (Afib) or atrial flutter (based on ECG at Visit 1):
≥600 pg/mL, or ≥400 pg/mL if hospitalized for HF within the past 12 months; or
b. For participants with atrial fibrillation or atrial flutter (based on ECG at Visit 1):
≥1200 pg/mL, regardless of prior HF hospitalization.
Receiving optimal standard-of-care (SOC) therapy for HF according to local/international guidelines, as feasible and per investigator’s judgment (excluding SGLT2 inhibitors [SGLT2i] and mineralocorticoid receptor antagonists [MRA]).
SOC therapy should generally include (unless contraindicated or not tolerated):
• An angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), or angiotensin receptor–neprilysin inhibitor (ARNi); and
• A beta-blocker; and
• An SGLT2 inhibitor if deemed appropriate by the treating physician
(prior SGLT2i therapy will be replaced by the investigational drug at randomization).
Additional inclusion criteria for the optional cardiac rhythm monitoring sub-study:
Willing and able to provide informed consent for participation in the sub-study.
Sinus rhythm confirmed on ECG at Visit 1.
Signed and dated written informed consent prior to trial entry, in accordance with the International Conference on Harmonisation – Good Clinical Practice (ICH-GCP) and applicable local laws.
Male or female participants.
Women of childbearing potential (WOCBP) must be willing and able to use a highly effective method of contraception as defined in ICH M3(R2), i.e., one that results in a failure rate of less than 1% per year when used consistently and correctly.
Diagnosis of chronic heart failure (HF) for at least 3 months prior to Visit 1, and classified as NYHA Class II–IV at Visit 1, with a locally measured left ventricular ejection fraction (LVEF) <40%, determined by echocardiography, radionuclide ventriculography, invasive angiography, MRI, or CT.
If a previous LVEF measurement within 12 months prior to Visit 1 is available, it may be used. Alternatively, LVEF may be measured after informed consent and before randomization at Visit 2.
If multiple LVEF assessments exist, the most recent value should be used.
Elevated N-terminal pro-B-type natriuretic peptide (NT-proBNP) at Visit 1, measured at the central laboratory, defined as:
a. For participants without atrial fibrillation (Afib) or atrial flutter (based on ECG at Visit 1):
≥600 pg/mL, or ≥400 pg/mL if hospitalized for HF within the past 12 months; or
b. For participants with atrial fibrillation or atrial flutter (based on ECG at Visit 1):
≥1200 pg/mL, regardless of prior HF hospitalization.
Receiving optimal standard-of-care (SOC) therapy for HF according to local/international guidelines, as feasible and per investigator’s judgment (excluding SGLT2 inhibitors [SGLT2i] and mineralocorticoid receptor antagonists [MRA]).
SOC therapy should generally include (unless contraindicated or not tolerated):
• An angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), or angiotensin receptor–neprilysin inhibitor (ARNi); and
• A beta-blocker; and
• An SGLT2 inhibitor if deemed appropriate by the treating physician
(prior SGLT2i therapy will be replaced by the investigational drug at randomization).
Additional inclusion criteria for the optional cardiac rhythm monitoring sub-study:
Willing and able to provide informed consent for participation in the sub-study.
Sinus rhythm confirmed on ECG at Visit 1.
Exclusion Criteria
Received mineralocorticoid receptor antagonist (MRA) therapy (e.g., spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1, or, in the investigator’s judgment, requires or is expected to require MRA treatment before randomization or during the trial. Ongoing MRA therapy should not be discontinued solely for trial participation.
Received amiloride or other potassium-sparing diuretics within 14 days prior to Visit 1, or, in the investigator’s judgment, requires or is expected to require such therapy before randomization or during the trial.
Receiving any of the following treatments:
• Direct renin inhibitors (e.g., aliskiren) at Visit 2.
• More than one ACE inhibitor (ACEi), angiotensin receptor blocker (ARB), or angiotensin receptor–neprilysin inhibitor (ARNi) at Visit 2.
• Other aldosterone synthase inhibitors (e.g., baxdrostat) at Visit 2 or planned during the study.
• Systemic mineralocorticoid replacement therapy (e.g., fludrocortisone) at Visit 2.
• In the case of acute decompensated heart failure (HF):
o Use of intravenous inotropes, vasodilators (e.g., nitrates, nitroprusside), or natriuretic peptides (e.g., nesiritide, carperitide), or mechanical support (e.g., intra-aortic balloon pump, intubation, mechanical ventilation, or ventricular assist device) within 24 hours before randomization.
o Escalated or intensified IV diuretic dosing within 6 hours prior to randomization (stable IV diuretic therapy is allowed).
Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass grafting (CABG), valve surgery/intervention, or any other major surgery (as judged by the investigator) within 90 days prior to Visit 2, or planned major non-urgent surgery (e.g., hip replacement, CABG) during the trial.
Percutaneous coronary intervention (PCI) or angiography using iodinated contrast media within 7 days prior to Visit 2.
Heart transplant recipient, on a waiting list for transplant, or currently implanted with a left ventricular assist device (LVAD).
Cardiomyopathy due to infiltrative disease (e.g., amyloidosis), storage disease (e.g., hemochromatosis, Fabry disease), muscular dystrophy, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, or reversible cardiomyopathy (e.g., stress-induced, peripartum, or chemotherapy-induced) diagnosed within 12 months prior to Visit 1 or up to Visit 2.
Acute inflammatory heart disease (e.g., acute myocarditis) within 90 days prior to Visit 2.
Severe valvular heart disease (stenotic or regurgitant, excluding secondary mitral regurgitation due to LV dilatation) or scheduled invasive valve procedure at Visit 1 or during the trial, per investigator judgment.
Atrial fibrillation or atrial flutter with resting heart rate >110 bpm on ECG at Visit 2.
Clinically significant untreated ventricular arrhythmia or not managed by antiarrhythmic medication or defibrillator therapy at Visit 1 and/or Visit 2.
Symptomatic bradycardia, sick sinus syndrome, Mobitz type II second-degree, or third-degree AV block unless treated with a permanent pacemaker.
Cardiac resynchronization therapy (CRT) device implanted within 3 months prior to Visit 1 or planned implantation up to Visit 2.
Symptomatic hypotension and/or systolic blood pressure (SBP) <100 mmHg at Visit 1 or Visit 2.
SBP ≥ 180 mmHg at Visit 1 or Visit 2. If SBP > 150 mmHg but < 180 mmHg at Visit 1, the participant must be on ≥3 antihypertensive agents.
Severe chronic pulmonary disease, defined as FEV₁ < 50%, requirement for home oxygen, pulmonary hypertension, chronic thromboembolic pulmonary hypertension (CTEPH), or COPD exacerbation requiring IV or prolonged oral steroids within 3 months prior to Visit 1 or up to Visit 2.
Serum potassium > 5.2 mmol/L at Visit 1 (central laboratory). One repeat test during screening is allowed.
ALT or AST > 3× upper limit of normal (ULN) at Visit 1, or known cirrhosis (Child-Pugh C), or other severe hepatic impairment per investigator judgment.
Renal impairment defined as estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m² (CKD-EPI) at Visit 1 (central lab), or currently on renal replacement therapy. One repeat eGFR test is allowed during screening.
Hemoglobin (Hb) < 9 g/dL at Visit 1 (central lab).
Known adrenal insufficiency (e.g., Addison’s disease) or Cushing’s syndrome.
History of ketoacidosis within 5 years prior to Visit 1 or up to Visit 2.
Prior gastrointestinal surgery or active GI disease that may interfere with absorption of study drug (e.g., bowel resection, inflammatory bowel disease, active gastritis, pancreatitis).
Type 1 diabetes mellitus or other autoimmune forms of diabetes (e.g., latent autoimmune diabetes in adults, LADA).
Active or suspected malignancy within 5 years prior to Visit 1 or up to Visit 2, except for adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or low-risk prostate cancer (pre-treatment PSA < 10 ng/mL, Gleason ≤ 6, and clinical stage T1c or T2a).
Any comorbidity other than HF with an expected life expectancy < 1 year, per investigator judgment.
Use or planned use of prohibited medications or any drugs likely to interfere with trial safety or outcomes.
Currently enrolled in another investigational drug or device trial, or participated within 30 days or 5 half-lives of the investigational product (whichever is longer). Participation in observational studies is permitted.
Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, would make the participant unreliable or unlikely to complete the trial.
Pregnant or breastfeeding women, or those likely to become pregnant during the trial.
Known intolerance, allergy, or hypersensitivity to vicadrostat, empagliflozin, other SGLT2 inhibitors, or any excipients (including lactose).
Any other condition not specifically listed that, in the investigator’s opinion, may place the participant at risk, compromise safety, or affect compliance, including abnormal lab findings or legal/administrative vulnerability (e.g., being detained by authorities or court order).
Additional Exclusion Criteria for the Optional Cardiac Rhythm Monitoring Sub-study
Known allergy, intolerance, or hypersensitivity to adhesives or hydrogels.
Presence of a pacemaker, implantable cardioverter-defibrillator (ICD), or CRT device.
History of permanent atrial fibrillation or atrial flutter.
Received amiloride or other potassium-sparing diuretics within 14 days prior to Visit 1, or, in the investigator’s judgment, requires or is expected to require such therapy before randomization or during the trial.
Receiving any of the following treatments:
• Direct renin inhibitors (e.g., aliskiren) at Visit 2.
• More than one ACE inhibitor (ACEi), angiotensin receptor blocker (ARB), or angiotensin receptor–neprilysin inhibitor (ARNi) at Visit 2.
• Other aldosterone synthase inhibitors (e.g., baxdrostat) at Visit 2 or planned during the study.
• Systemic mineralocorticoid replacement therapy (e.g., fludrocortisone) at Visit 2.
• In the case of acute decompensated heart failure (HF):
o Use of intravenous inotropes, vasodilators (e.g., nitrates, nitroprusside), or natriuretic peptides (e.g., nesiritide, carperitide), or mechanical support (e.g., intra-aortic balloon pump, intubation, mechanical ventilation, or ventricular assist device) within 24 hours before randomization.
o Escalated or intensified IV diuretic dosing within 6 hours prior to randomization (stable IV diuretic therapy is allowed).
Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass grafting (CABG), valve surgery/intervention, or any other major surgery (as judged by the investigator) within 90 days prior to Visit 2, or planned major non-urgent surgery (e.g., hip replacement, CABG) during the trial.
Percutaneous coronary intervention (PCI) or angiography using iodinated contrast media within 7 days prior to Visit 2.
Heart transplant recipient, on a waiting list for transplant, or currently implanted with a left ventricular assist device (LVAD).
Cardiomyopathy due to infiltrative disease (e.g., amyloidosis), storage disease (e.g., hemochromatosis, Fabry disease), muscular dystrophy, hypertrophic obstructive cardiomyopathy, constrictive pericarditis, or reversible cardiomyopathy (e.g., stress-induced, peripartum, or chemotherapy-induced) diagnosed within 12 months prior to Visit 1 or up to Visit 2.
Acute inflammatory heart disease (e.g., acute myocarditis) within 90 days prior to Visit 2.
Severe valvular heart disease (stenotic or regurgitant, excluding secondary mitral regurgitation due to LV dilatation) or scheduled invasive valve procedure at Visit 1 or during the trial, per investigator judgment.
Atrial fibrillation or atrial flutter with resting heart rate >110 bpm on ECG at Visit 2.
Clinically significant untreated ventricular arrhythmia or not managed by antiarrhythmic medication or defibrillator therapy at Visit 1 and/or Visit 2.
Symptomatic bradycardia, sick sinus syndrome, Mobitz type II second-degree, or third-degree AV block unless treated with a permanent pacemaker.
Cardiac resynchronization therapy (CRT) device implanted within 3 months prior to Visit 1 or planned implantation up to Visit 2.
Symptomatic hypotension and/or systolic blood pressure (SBP) <100 mmHg at Visit 1 or Visit 2.
SBP ≥ 180 mmHg at Visit 1 or Visit 2. If SBP > 150 mmHg but < 180 mmHg at Visit 1, the participant must be on ≥3 antihypertensive agents.
Severe chronic pulmonary disease, defined as FEV₁ < 50%, requirement for home oxygen, pulmonary hypertension, chronic thromboembolic pulmonary hypertension (CTEPH), or COPD exacerbation requiring IV or prolonged oral steroids within 3 months prior to Visit 1 or up to Visit 2.
Serum potassium > 5.2 mmol/L at Visit 1 (central laboratory). One repeat test during screening is allowed.
ALT or AST > 3× upper limit of normal (ULN) at Visit 1, or known cirrhosis (Child-Pugh C), or other severe hepatic impairment per investigator judgment.
Renal impairment defined as estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73 m² (CKD-EPI) at Visit 1 (central lab), or currently on renal replacement therapy. One repeat eGFR test is allowed during screening.
Hemoglobin (Hb) < 9 g/dL at Visit 1 (central lab).
Known adrenal insufficiency (e.g., Addison’s disease) or Cushing’s syndrome.
History of ketoacidosis within 5 years prior to Visit 1 or up to Visit 2.
Prior gastrointestinal surgery or active GI disease that may interfere with absorption of study drug (e.g., bowel resection, inflammatory bowel disease, active gastritis, pancreatitis).
Type 1 diabetes mellitus or other autoimmune forms of diabetes (e.g., latent autoimmune diabetes in adults, LADA).
Active or suspected malignancy within 5 years prior to Visit 1 or up to Visit 2, except for adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or low-risk prostate cancer (pre-treatment PSA < 10 ng/mL, Gleason ≤ 6, and clinical stage T1c or T2a).
Any comorbidity other than HF with an expected life expectancy < 1 year, per investigator judgment.
Use or planned use of prohibited medications or any drugs likely to interfere with trial safety or outcomes.
Currently enrolled in another investigational drug or device trial, or participated within 30 days or 5 half-lives of the investigational product (whichever is longer). Participation in observational studies is permitted.
Chronic alcohol or drug abuse or any condition that, in the investigator’s opinion, would make the participant unreliable or unlikely to complete the trial.
Pregnant or breastfeeding women, or those likely to become pregnant during the trial.
Known intolerance, allergy, or hypersensitivity to vicadrostat, empagliflozin, other SGLT2 inhibitors, or any excipients (including lactose).
Any other condition not specifically listed that, in the investigator’s opinion, may place the participant at risk, compromise safety, or affect compliance, including abnormal lab findings or legal/administrative vulnerability (e.g., being detained by authorities or court order).
Additional Exclusion Criteria for the Optional Cardiac Rhythm Monitoring Sub-study
Known allergy, intolerance, or hypersensitivity to adhesives or hydrogels.
Presence of a pacemaker, implantable cardioverter-defibrillator (ICD), or CRT device.
History of permanent atrial fibrillation or atrial flutter.
The Estimated Number of Participants
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Taiwan
70 participants
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Global
6000 participants
