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BI 690517 + Empagliflozin for Heart Failure
Phase 3
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years
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
Must not have
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), or two simultaneously at Visit 2, 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, 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), Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD), 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, Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2, 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
Treatment with a 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 42 months
Awards & highlights
Summary
"This trial is looking for adults with heart failure to see if a combination of BI 690517 and empagliflozin can help. Participants will be split into two groups by chance: one
Who is the study for?
Adults with heart failure, having symptoms and a left ventricular ejection fraction of 40% or higher can join. They must be on stable diuretic therapy, have been hospitalized for heart failure within the last 6 months, and fit specific criteria based on body mass index and presence of atrial fibrillation or flutter.
What is being tested?
The trial is testing BI 690517 combined with empagliflozin against a placebo combined with empagliflozin in people with heart failure. Participants are randomly assigned to one of these two groups and take the tablets daily while their health is monitored over time.
What are the potential side effects?
While not specified here, common side effects may include changes in blood pressure, kidney function issues, low blood sugar levels (in diabetic patients), urinary tract infections due to increased urination from empagliflozin, and potential unknown side effects from BI 690517.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 18 years old or the legal age of consent in my country.
Select...
I am using or willing to use effective birth control if I can have children.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken drugs like spironolactone or eplerenone in the last 14 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 42 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 42 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Absolute change from baseline in KCCQ Clinical Summary Score (KCCQ-CSS) at Week 32
Key secondary endpoint: Absolute change from baseline in Kansas City Cardiomyopathy Questionnaire Total Symptom Score (KCCQ-TSS) at Week 32
Time to first occurrence of death from kidney failure, chronic dialysis* or renal transplant or sustained reduction of ≥40% estimated glomerular filtration rate (eGFR)** or sustained eGFR (CKD-EPI)cr <10 mL/min/1.73 m² (composite renal endpoint)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 690517 + empagliflozinExperimental Treatment2 Interventions
Group II: Placebo + empagliflozinPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Empagliflozin
2017
Completed Phase 4
~181750
BI 690517
2017
Completed Phase 2
~1040
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Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,534 Previous Clinical Trials
11,351,527 Total Patients Enrolled
26 Trials studying Heart Failure
119,926 Patients Enrolled for Heart Failure
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