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A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients with Heart Failure Who Are Intolerant or Not Eligible for Treatment with Steroidal Mineralocorticoid Receptor Antagonists.
EU CTIS ID: 2023-508875-35-00
What this study is testing
The primary objective is to evaluate the efficacy and safety of finerenone in participants with HFrEF who are intolerant of or not eligible for treatment with sMRA. The safety objective is to assess safety and tolerability of finerenone.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 2. Age ≥18 years or legal age of majority if >18 years in the participant’s country of residence.
- 3. Symptomatic HFrEF (must meet all criteria) • NYHA class II – IV symptoms at screening and randomization • Most recent ejection fraction <40% by imaging (e.g., echocardiogram, cardiac MRI, nuclear scan) within 12 months prior to screening • Qualifying natriuretic peptide level: Most recent local laboratory value within 14 days of randomization for patients with recent HHF (discharged within prior 10 days) or within 30 days for patients without recent HHF must meet the qualifying threshold below. If no value is available in the medical record, a local lab value must be obtained. Note: for participants treated with an angiotensin receptor/neprilysin inhibitor (ARNI) in the previous 4 weeks prior to natriuretic peptide measurement, only NTproBNP values should be used.
- 4. Not on sMRA (i.e., spironolactone, eplerenone or canrenone/potassium canrenoate) due to documented history of being either intolerant, contraindicated (e.g., due to eGFR <30 mL/min/1.73m2) or considered ineligible for treatment with sMRA . • Intolerance is defined as at least one episode of hyperkalemia, or an episode of worsening kidney function, or an episode of sexual side effects or hypotension, each leading to drug interruption or discontinuation. • Ineligibility is in the opinion of the treating physician and/or investigator.
- 5. Persons of childbearing potential can only be included in the study if a pregnancy test is negative at screening and if they agree to use highly effective contraception which is consistent with local regulations regarding the methods for contraception for the duration of the study.
- 1. Provide written informed consent.
You likely can't join if
- 1. Treatment with any MRA (e.g., spironolactone, eplerenone, finerenone, esaxerenone, apararenone) within 30 days prior to randomization; treatment with any MRA should not be interrupted for the purpose of enrollment into the study.
- 10. Concomitant treatment with: a) systemic potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g., itraconazole, ritonavir, indinavir, cobicistat, clarithromycin), or moderate CYP3A4 inducers (e.g., efavirenz, phenobarbital), or potent CYP3A4 inducers (e.g., carbamazepine, phenytoin, St John’s Wort) that cannot be discontinued 7 days prior to randomization and for the duration of the treatment period (note: a list of prohibited concomitant medications and excluded and allowed CYP3A4 inhibitors and inducers is provided in Appendix D); b) or a renin inhibitor or more than one of an angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin-receptor-neprilysin-inhibitor (ARNI); c) or a potassium-sparing diuretic that cannot be stopped prior to randomization and for the duration of the treatment period.
- 11. Known hypersensitivity to the IP (active substance or excipients)
- 12. Any other condition or therapy (e.g., breastfeeding, cardiogenic shock, clinically overt severe hepatic insufficiency [Child Pugh C], Addison’s disease, malignancy or other severe condition as per investigator’s judgment such as disease with <1 year life expectancy) which would make the participant unsuitable for this study and not allow participation for the full planned study period
- 13. Concurrent or previous participation in another interventional clinical study using an investigational agent (e.g., not approved for any indication) within 30 days or 5 half-lives of the study drug, whichever is longer, prior to randomization.
- 2. Documented prior history of severe hyperkalemia (potassium ≥6.0 mmol/L and/or resulting in hospitalization or Emergency Department visit) in the setting of MRA use
See the full eligibility criteria
Who can join
- 2. Age ≥18 years or legal age of majority if >18 years in the participant’s country of residence.
- 3. Symptomatic HFrEF (must meet all criteria) • NYHA class II – IV symptoms at screening and randomization • Most recent ejection fraction <40% by imaging (e.g., echocardiogram, cardiac MRI, nuclear scan) within 12 months prior to screening • Qualifying natriuretic peptide level: Most recent local laboratory value within 14 days of randomization for patients with recent HHF (discharged within prior 10 days) or within 30 days for patients without recent HHF must meet the qualifying threshold below. If no value is available in the medical record, a local lab value must be obtained. Note: for participants treated with an angiotensin receptor/neprilysin inhibitor (ARNI) in the previous 4 weeks prior to natriuretic peptide measurement, only NTproBNP values should be used.
- 4. Not on sMRA (i.e., spironolactone, eplerenone or canrenone/potassium canrenoate) due to documented history of being either intolerant, contraindicated (e.g., due to eGFR <30 mL/min/1.73m2) or considered ineligible for treatment with sMRA . • Intolerance is defined as at least one episode of hyperkalemia, or an episode of worsening kidney function, or an episode of sexual side effects or hypotension, each leading to drug interruption or discontinuation. • Ineligibility is in the opinion of the treating physician and/or investigator.
- 5. Persons of childbearing potential can only be included in the study if a pregnancy test is negative at screening and if they agree to use highly effective contraception which is consistent with local regulations regarding the methods for contraception for the duration of the study.
- 1. Provide written informed consent.
What rules you out
- 1. Treatment with any MRA (e.g., spironolactone, eplerenone, finerenone, esaxerenone, apararenone) within 30 days prior to randomization; treatment with any MRA should not be interrupted for the purpose of enrollment into the study.
- 10. Concomitant treatment with: a) systemic potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors (e.g., itraconazole, ritonavir, indinavir, cobicistat, clarithromycin), or moderate CYP3A4 inducers (e.g., efavirenz, phenobarbital), or potent CYP3A4 inducers (e.g., carbamazepine, phenytoin, St John’s Wort) that cannot be discontinued 7 days prior to randomization and for the duration of the treatment period (note: a list of prohibited concomitant medications and excluded and allowed CYP3A4 inhibitors and inducers is provided in Appendix D); b) or a renin inhibitor or more than one of an angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or angiotensin-receptor-neprilysin-inhibitor (ARNI); c) or a potassium-sparing diuretic that cannot be stopped prior to randomization and for the duration of the treatment period.
- 11. Known hypersensitivity to the IP (active substance or excipients)
- 12. Any other condition or therapy (e.g., breastfeeding, cardiogenic shock, clinically overt severe hepatic insufficiency [Child Pugh C], Addison’s disease, malignancy or other severe condition as per investigator’s judgment such as disease with <1 year life expectancy) which would make the participant unsuitable for this study and not allow participation for the full planned study period
- 13. Concurrent or previous participation in another interventional clinical study using an investigational agent (e.g., not approved for any indication) within 30 days or 5 half-lives of the study drug, whichever is longer, prior to randomization.
- 2. Documented prior history of severe hyperkalemia (potassium ≥6.0 mmol/L and/or resulting in hospitalization or Emergency Department visit) in the setting of MRA use
- 3. eGFR <25 mL/min/1.73m² and / or potassium >5.0 mmol/L at screening (most recent value within 14 days of randomization if acutely hospitalized or discharged within the last 10 days; within 30 days of randomization if no recent hospitalization). Note: eGFR and potassium should be repeated prior to randomization if renin-angiotensin system antagonist started or dose increased since most recent prior measurement
- 4. Acute MI, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days prior to randomization or planned (note: pacemakers or implantable cardioverter defibrillators without resynchronization function are allowed)
- 5. Prior heart transplant or listed for heart transplant with expectation to receive a transplant during the course of this trial (according to investigator judgement) or currently using or plan for mechanical circulatory support, e.g., left ventricular assist device, intra-aortic balloon pump, or participants on mechanical ventilation or participants with planned outpatient inotropic support
- 6. Hemodynamically significant (severe) uncorrected primary cardiac valvular disease considered by the investigator to be the primary cause of heart failure (note: secondary mitral regurgitation or tricuspid regurgitation due to dilated cardiomyopathy is not excluded unless planned for surgery or intervention during the course of the study)
- 7. Symptomatic bradycardia or second- or third-degree heart block without a pacemaker
- 8. Cardiomyopathy due to known acute inflammatory heart disease (e.g., acute myocarditis within 90 days prior to randomization), infiltrative diseases (e.g., amyloidosis), accumulation diseases (e.g., haemochromatosis, Fabry disease), muscular dystrophies, cardiomyopathy with reversible causes (e.g., stress cardiomyopathy), known hypertrophic obstructive cardiomyopathy, complex (according to investigator`s judgement) congenital heart disease, or known pericardial constriction
- 9. Probable alternative cause of participant’s HF symptoms that, in the opinion of the investigator, primarily accounts for patient’s symptoms; specifically, participants with severe pulmonary disease requiring home oxygen or chronic oral steroid therapy, primary pulmonary arterial hypertension at screening
The study team makes the final eligibility decision.
Where it's taking place
- Argentina
- Mexico
- Japan
- Canada
- Brazil
- United Kingdom
- Sri Lanka
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Argentina; Mexico; Japan; Canada; Brazil; United Kingdom and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.