BridgeMD
202301CPC Redefine-HF
EU CTIS ID: 2023-508581-15-00
What this study is testing
To determine whether finerenone reduces total (first and subsequent) HF events and CV death compared with placebo in patients hospitalized with acute decompensated HFmrEF/HFpEF.
- 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. Current hospitalization or recently discharged (during or within 30 days of discharge) with a primary diagnosis of acute HF.
- 4. Heart failure signs and symptoms at the time of hospital admission, including: a. Symptoms (at least one of the following): persistent dyspnea at rest or with minimal exertion worse than baseline, or new or worsening orthopnea b. Signs of fluid overload (at least one of the following): congestion on chest X-ray, rales on chest auscultation, clinically relevant edema (as judged by the investigator), elevated jugular venous pressure
- 5. Imaging evidence of mildly reduced or preserved EF (40% or higher) per local reading on the most recent assessment, preferably measured during current hospitalization; a historical left ventricular EF (LVEF) assessment may be used if there is no in-hospital measurement and if it was measured within 12 months prior to screening provided there was no major intervening event affecting EF such as an MI
- 6. Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL according to the local lab for patients without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF, measured during the current hospitalization, in the 72 hours prior to hospital admission, or during the 30 days post-discharge. (Note: for patients treated with an angiotensin receptor neprilysin inhibitor [ARNI] in the previous 4 weeks prior to randomization, NTproBNP values should be used where available).
- 7. Fulfillment of the following stabilization criteria (if randomized during hospitalization): a. Systolic blood pressure (BP) ≥100 mmHg and no symptoms of hypotension in the 6 hours prior to randomization b. No increase in intravenous diuretic dose for 6 hours prior to randomization c. No intravenous vasodilators, including nitrates, within the last 6 hours prior to randomization d. No intravenous inotropic drugs or mechanical circulatory support for 24 hours prior to randomization
You likely can't join if
- 1. Currently on or planned for long-term therapy with an MRA (finerenone, spironolactone, eplerenone, canrenone, esaxerenone); treatment with MRA should not be interrupted for the purpose of enrollment into the study. (Note: patients with recent MRA exposure should not be randomized/receive study treatment until 7 days from the last dose to allow adequate washout).
- 7. 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
- 8. Probable alternative cause of participant’s HF symptoms that, in the opinion of the investigator, primarily accounts for patient’s symptoms; specifically, patients with severe pulmonary disease requiring home oxygen or chronic oral steroid therapy, primary pulmonary arterial hypertension at screening
- 9. Concomitant systemic therapy with 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 excluded CYP3A4 inhibitors and inducers is provided in Appendix D.
- 11. Known hypersensitivity to the IP (active substance or excipients).
- 10. Concomitant treatment with renin inhibitor, more than one angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or ARNI, or with a potassium-sparing diuretic that cannot be stopped prior to randomization and for the duration of the treatment period
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. Current hospitalization or recently discharged (during or within 30 days of discharge) with a primary diagnosis of acute HF.
- 4. Heart failure signs and symptoms at the time of hospital admission, including: a. Symptoms (at least one of the following): persistent dyspnea at rest or with minimal exertion worse than baseline, or new or worsening orthopnea b. Signs of fluid overload (at least one of the following): congestion on chest X-ray, rales on chest auscultation, clinically relevant edema (as judged by the investigator), elevated jugular venous pressure
- 5. Imaging evidence of mildly reduced or preserved EF (40% or higher) per local reading on the most recent assessment, preferably measured during current hospitalization; a historical left ventricular EF (LVEF) assessment may be used if there is no in-hospital measurement and if it was measured within 12 months prior to screening provided there was no major intervening event affecting EF such as an MI
- 6. Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL according to the local lab for patients without atrial fibrillation (AF); or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with AF, measured during the current hospitalization, in the 72 hours prior to hospital admission, or during the 30 days post-discharge. (Note: for patients treated with an angiotensin receptor neprilysin inhibitor [ARNI] in the previous 4 weeks prior to randomization, NTproBNP values should be used where available).
- 7. Fulfillment of the following stabilization criteria (if randomized during hospitalization): a. Systolic blood pressure (BP) ≥100 mmHg and no symptoms of hypotension in the 6 hours prior to randomization b. No increase in intravenous diuretic dose for 6 hours prior to randomization c. No intravenous vasodilators, including nitrates, within the last 6 hours prior to randomization d. No intravenous inotropic drugs or mechanical circulatory support for 24 hours prior to randomization
- 8. Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic, e.g. furosemide, torsemide, bumetanide
- 9. Women of childbearing potential can only be included in the study if a pregnancy test is negative at screening and if they agree to use adequate 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. Currently on or planned for long-term therapy with an MRA (finerenone, spironolactone, eplerenone, canrenone, esaxerenone); treatment with MRA should not be interrupted for the purpose of enrollment into the study. (Note: patients with recent MRA exposure should not be randomized/receive study treatment until 7 days from the last dose to allow adequate washout).
- 7. 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
- 8. Probable alternative cause of participant’s HF symptoms that, in the opinion of the investigator, primarily accounts for patient’s symptoms; specifically, patients with severe pulmonary disease requiring home oxygen or chronic oral steroid therapy, primary pulmonary arterial hypertension at screening
- 9. Concomitant systemic therapy with 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 excluded CYP3A4 inhibitors and inducers is provided in Appendix D.
- 11. Known hypersensitivity to the IP (active substance or excipients).
- 10. Concomitant treatment with renin inhibitor, more than one angiotensin converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB) or ARNI, or with a potassium-sparing diuretic that cannot be stopped prior to randomization and for the duration of the treatment period
- 12. Any other condition or therapy (e.g., breastfeeding, cardiogenic shock, clinically overt severe hepatic insufficiency, Addison’s disease, 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. Participation in another interventional clinical study or treatment with another investigational medicine or device within 30 days 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 or potassium >5.0 mmol/L at screening.
- 4. Acute MI due to plaque rupture, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days prior to randomization (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 planned for palliative care for HF, or currently using or plan for mechanical circulatory support, e.g., left ventricular assist device, intra-aortic balloon pump, or patients on mechanical ventilation or patients 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)
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Argentina
- India
- United Kingdom
- Australia
- Canada
- Sri Lanka
- Mexico
- Brazil
- Colombia
- Malaysia
- Taiwan
- 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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Argentina; India; United Kingdom; Australia; Canada and 7 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.