Clinical Trials List
2024-07-30 - 2028-09-30
Phase III
Not yet recruiting8
Recruiting2
EASi-HF – A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral 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%
-
Trial Applicant
IQVIA RDS Taiwan Ltd.
-
Sponsor
Jaana Harjula
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/11/13
Investigators and Locations
Co-Principal Investigator
- Chun-Yuan Chu Division of Cardiovascular Diseases
- Ye-Hsu Lu Division of Cardiovascular Diseases
- Wei-Chung Tsai Division of Cardiovascular Diseases
- Cheng-An Chiu 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 Not yet recruiting
Co-Principal Investigator
- 林柏志 無
- 賀立婷 無
- 洪啟盛 無
- HUNG-JU LIN 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Shih-Hsien Sung 無
- Tze-Fan Chao 無
- 郭泠 無
- 吳承學 無
- 李慶威 無
- Tse-Min Lu 無
- 張俊欽 無
- 廖若男 無
- Wen-Chung Yu 無
- 黃偉銘 無
- 蔡依霖 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
6820401000
Dosage Form
116
Dosage
10mg
Endpoints
Time to first event of CV death or HHF. Death and HHF will
be categorised by the investigator according to pre-specified
criteria
Key secondary endpoints:
Time to first event of CV death, HHF or urgent heart failure
visit
Occurrences of HHFs (first and recurrent)
Absolute change from baseline in KCCQ-TSS at Week 32
Time to CV death
Time to all-cause mortality
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 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-proBNP at Visit 1, analysed at the central laboratory at Visit 1:
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)
7. At least one of the following:
a) 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
b) Documented hospitalisation for HF within 6 months prior to Visit 1
c) Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1
a. in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg/mL
b. for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg/mL
8. Participants must be treated according to best possible SOC in accordance with
applicable HF local/international guidelines (according to the judgment of the
investigator)
Additional inclusion criteria apply to the optional accelerometry substudy:
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, or two simultaneously at Visit 2
c. Acute decompensated HF requiring hospitalisation or i.v. therapy including
diuretics, or i.v. inotropes or i.v. vasodilators, mechanical support (such as an
intra-aortic balloon pump, endotracheal intubation, mechanical ventilation,
any ventricular assist device), or IV natriuretic peptide (e.g. nesiritide) within
the past 7 days prior to Visit 2
4. MI, CVA, TIA, stroke, coronary artery bypass graft surgery/CABG, heart valve
surgery or any other major surgery (major according to the investigator’s assessment)
within 90 days prior to Visit 1, or scheduled for major elective surgery (e.g. hip
replacement, coronary artery bypass graft surgery/CABG)
5. Heart transplant recipient, awaiting heart transplant, or currently implanted LVAD
6. 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 the 12 months
prior to Visit 1 and until Visit 2
7. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days
preceding prior to Visit 1and until Visit 2
8. 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
9. Atrial fibrillation or Atrial flutter with a resting heart rate >110 bpm documented by
ECG at Visit 1
The Estimated Number of Participants
-
Taiwan
150 participants
-
Global
6000 participants
