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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% (EASi-HF)

A study to test whether BI 690517 in combination with empagliflozin helps people with heart failure (EASi-HF)

Amiorkov Mihail

IQVIA Services Japan G.K.

4-10-18 Takanawa, Minato-ku, Tokyo, 108-0074

mihail.amiorkov@iqvia.com

IQVIA Services Japan G.K. jRCT Inquiry Receipt Center

IQVIA Services Japan G.K.

4-10-18 Takanawa, Minato-ku, Tokyo, 108-0074

+81-3-6859-9500

yoshimi.kobayashi@iqvia.com

Recruiting

Aug. 01, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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) 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
4.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 Visit 2
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). 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
6.Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:
a) 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)
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 standard of care (SOC) in accordance with applicable HF local/international guidelines (according to the judgment of the investigator)

1.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
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 angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (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.Myocardial infarction (MI), cerebrovascular accident (CVA), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, 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 left ventricular assist device (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 1 and 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 Further exclusion criteria apply.

Both

Heart Failure

BI 690517
Empagliflozin

Time to first event of Cardiovascular (CV) death or Hospitalisation for heart failure (HHF)

July. 19, 2024

Yes

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed ""Document Sharing Agreement"". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

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