2023-508581-15-00招募中3 期
RandomizEd trial to DEtermine the efficacy and safety of FINErenone on morbidity and mortality among heart failure patients with left ventricular ejection fraction greater than or equal to 40% hospitalized due to an episode of acute decompensated Heart Failure (REDEFINE-HF)
Colorado Prevention Center, George Clinical Netherlands B.V.62 个研究点 分布在 8 个国家目标入组 1,136 人开始时间: 2024年6月24日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,136
- 试验地点
- 62
- 主要终点
- The primary study endpoint is a composite of total (first and subsequent) HF events (HF hospitalization or urgent visit for worsening HF) and CV death.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Participant must be age ≥18 years of age inclusive at the time of signing the informed consent
- •Current hospitalization or recently discharged (within 10 days prior to screening) with the primary diagnosis of HF
- •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
- •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
- •Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥1000 pg/mL or B-type natriuretic peptide (BNP) ≥250 pg/mL according to the local lab for patients without atrial fibrillation (AF); or elevated NTproBNP ≥2000 pg/mL or BNP ≥500 pg/mL for patients with AF, measured during the current hospitalization or in the 72 hours prior to hospital admission. (Note: for patients treated with an angiotensin receptor neprilysin inhibitor [ARNI] in the previous 4 weeks prior to randomization, only NTproBNP values should be used.)
- •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
- •Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic, e.g. furosemide, torsemide, bumetanide
- •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
排除标准
- •Treatment with an MRA (finerenone, spironolactone, eplerenone, canrenone, esaxerenone) within 30 days prior to randomization; treatment with MRA should not be interrupted for the purpose of enrollment into the study
- •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
- •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
- •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.
- •Known hypersensitivity to the study intervention (active substance or excipients)
- •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
- •Any other condition or therapy (e.g., 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
- •Participation in another interventional clinical study or treatment with another investigational medicine or device within 30 days prior to randomization
- •Documented prior history of severe hyperkalemia (serum/plasma K ≥6.0 mmol/L and/or resulting in hospitalization or Emergency Department visit) in the setting of MRA use
- •eGFR <25 mL/min/1.73m² or serum/plasma potassium >5.0 mmol/L at screening
- •Acute MI, 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.)
- •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
- •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)
结局指标
主要结局
The primary study endpoint is a composite of total (first and subsequent) HF events (HF hospitalization or urgent visit for worsening HF) and CV death.
The primary study endpoint is a composite of total (first and subsequent) HF events (HF hospitalization or urgent visit for worsening HF) and CV death.
次要结局
- Secondary endpoints include treatment group difference in: 1.Time to first occurrence of the composite of CV death or HF event; 2. Total HF events; 3. Change from baseline to month 6 in KCCQ-TSS; 4. Time to CV death 5. Time to death from any cause
研究者
Marc Bonaca
Scientific
Colorado Prevention Center
研究点 (62)
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