Clinical Trials List
2024-07-30 - 2028-09-30
Phase III
Recruiting10
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 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%
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
Jaana Harjula
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Chun-Yuan Chu Division of Cardiovascular Diseases
- Ye-Hsu Lu Division of Cardiovascular Diseases
- Cheng-An Chiu Division of Cardiovascular Diseases
- Wei-Chung Tsai 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
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 洪啟盛 Division of Cardiovascular Diseases
- 賀立婷 Division of Cardiovascular Diseases
- 林柏志 Division of Cardiovascular Diseases
- HUNG-JU LIN 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
- 張俊欽 Division of Cardiovascular Diseases
- Tze-Fan Chao Division of Cardiovascular Diseases
- Hao-min Cheng Division of Cardiovascular Diseases
- 吳承學 Division of Cardiovascular Diseases
- 郭泠 Division of Cardiovascular Diseases
- 蔡依霖 Division of Cardiovascular Diseases
- 黃偉銘 Division of Cardiovascular Diseases
- Tse-Min Lu Division of Cardiovascular Diseases
- Chern-En Chiang Division of Cardiovascular Diseases
- 李慶威 Division of Cardiovascular Diseases
- 廖若男 Division of Cardiovascular Diseases
- Kang-Ling Wang Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 周宗川 Division of Cardiovascular Diseases
- 葉日凱 Division of Cardiovascular Diseases
- 蕭富致 Division of Cardiovascular Diseases
- 陳東藝 Division of Cardiovascular Diseases
- 王俊力 Division of Cardiovascular Diseases
- 周星賢 Division of Cardiovascular Diseases
- 董穎璋 Division of Cardiovascular Diseases
- 謝明哲 Division of Cardiovascular Diseases
- 吳家棟 Division of Cardiovascular Diseases
- 洪國竣 Division of Cardiovascular Diseases
- 徐子哲 Division of Cardiovascular Diseases
- 沃宏達 Division of Cardiovascular Diseases
- 張伯丞 Division of Cardiovascular Diseases
- 盧政諱 Division of Cardiovascular Diseases
- 鄭郁雯 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳志維
- 洪元 Division of Cardiovascular Diseases
- 陳彥舟
- Chien-Yi Hsu
- 鄭宇倫
- Yung-Ta Kao
- 蕭卜源
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Empagliflozin
Dosage Form
116
Dosage
Endpoints
visit. CV death includes death of undetermined cause.
Death, HHF, and urgent HF visit will be categorised by the investigator according to pre-
specified criteria as defined in Appendix 10.2. Central adjudication of outcome events is not
planned.
Inclution Criteria
criteria below.
1. At least 18 years old and at least of the legal age of consent in countries where it is
greater than 18 years
2. Signed and dated written informed consent in accordance with ICH-GCP and local
legislation prior to admission to the trial
3. Male or female participants. Women of childbearing potential (WOCBP; see
Section 4.2.2.3)1 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 in Section 4.2.2.3
4. Chronic HF diagnosed at least 3 months before Visit 1, and in NYHA class II-IV at
Visit 1, with LVEF ≥40% per local reading (obtained by echocardiography,
radionuclide ventriculography, invasive angiography, MRI, or CT). 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 (if several values are available, the most recent one should be considered)
5. 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) (see Appendix 10.3). 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. If several values are available, the most recent
one should be considered
6. Elevated NT-proBNP2,3 at Visit 1, analysed at the central laboratory at Visit 1 (see
SoA):
a. in participants with BMI <27 kg/m2: ≥300 pg/mL for participants without Afib
or Aflutter (at Visit 1 ECG) and ≥900 pg/mL for participants with Afib or
Aflutter (at Visit 1 ECG)
b. 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)
c. 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)
Exclusion Criteria
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
2. 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
3. Receiving the following treatments:
a. A direct renin inhibitor (e.g. aliskiren) at Visit 2
b. More than one ACEI, ARB or ARNI used simultaneously at Visit 2
c. In case of acute decompensated HF:
i. 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)
ii. 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)
d. Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at
Visit 2
e. Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned
during the trial
4. MI, 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)
5. Percutaneous coronary intervention (PCI, scheduled or unscheduled) or any
angiography using iodinated contrast agents in the 7 days prior to Visit 2
6. Heart transplant recipient, awaiting heart transplant, or currently implanted LVAD
7. 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
8. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days
preceding prior to Visit 1and until Visit 2
9. 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
10. Atrial fibrillation or Atrial flutter with a resting heart rate >110 bpm documented by
ECG at Visit 2
The Estimated Number of Participants
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Taiwan
150 participants
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Global
6000 participants
