EUCTR2020-000306-29-HU进行中（未招募）1 期
A multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction = 40% (LVEF = 40%). - FINEARTS-HF
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 5,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Participant (male or female) must be aged 40 years and older, at the time of signing the informed consent.
- •2. Diagnosis of heart failure with NYHA class II–IV, ambulatory or hospitalized primarily for heart failure.
- •3. On diuretics treatment for at least 30 days prior to randomization.
- •4. Documented LVEF of =40% measured by any modality within the last 12 months.
- •5. Structural heart abnormalities based on any local imaging measurement within the last 12 months, defined by at least one of the following findings: LAD =3.8cm, LAA =20cm² , LAVI >30 mL/m² , LVMI =115 g/m² (?)/ 95 g/m² (?), septal thickness or posterior wall thickness =1.1 cm.
- •6. NT-proBNP =300 pg/mL (BNP = 100 pg/mL) in SR or NT-proBNP =900pg/mL (BNP = 300 pg/mL) in AF obtained at the following time:
- •- Within 90 days prior to randomization if patient had been hospitalized for HF requiring initiation or change in HF therapy or if patient had an urgent visit for HF requiring intravenous (IV) diuretic therapy, both within 90 days prior to randomization.
- •- Within 30 days prior to randomization if patient has not been hospitalized for HF nor had an urgent HF visit within the past 90 days.
- •7. Women of childbearing potential can only be included in the study if a pregnancy test is negative at screening and baseline and if they agree to use adequate contraception which is consistent with local regulations regarding the methods for contraception for those participating in clinical trials.
- •8. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4000
排除标准
- •1. eGFR <25 mL/min/1.73 m² at either screening or randomization visit.
- •2. Serum/plasma potassium >5.0 mmol/L at either screening or randomization visit.
- •3. Acute inflammatory heart disease, e.g. acute myocarditis, within 90 days prior to randomization
- •4. Myocardial infarction or any event which could have reduced the ejection fraction within 90 days prior to randomization
- •5. Coronary artery bypass graft surgery in the 90 days prior to randomization
- •6. Percutaneous coronary intervention in the 30 days prior to randomization
- •7. Stroke or transient ischemic cerebral attack within 90 days prior to randomization
- •8. Probable alternative cause of participants’ HF symptoms that in the opinion of the investigator primarily accounts for patient’s dyspnea such as significant pulmonary disease, anemia or obesity. Specifically, patients with the below are excluded:
- •- Severe pulmonary disease requiring home oxygen, or chronic oral steroid therapy
- •- History of primary pulmonary arterial hypertension
- •- Hemoglobin <10 g/dl
- •- Valvular heart disease considered by the investigator to be clinically significant
- •- BMI >50 kg/m2 at screening
- •9. SBP =160 mmHg if not on treatment with =3 blood pressure lowering medications or =180 mmHg irrespective of treatments, on 2 consecutive measurements at least 2-minute apart, at screening or at randomization
- •10. Life-threatening or uncontrolled arrhythmias at screening and/or randomization including but not limited to sustained ventricular tachycardia and atrial fibrillation, or atrial flutter with resting ventricular rate >110 bpm
- •11. Symptomatic hypotension with mean systolic blood pressure <90 mmHg at screening or at randomization
- •12. Any primary cause of HF scheduled for surgery, e.g. valve disease such as severe aortic stenosis or severe mitral regurgitation by the time of screening or randomization
- •13. History of peripartum cardiomyopathy, chemotherapy induced cardiomyopathy, viral myocarditis, right heart failure in absence of left-sided structural disease, pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative
- •cardiomyopathy including amyloidosis
- •14. Presence of left ventricular assist device by the time of screening or randomization
- •15. History of hyperkalemia or acute renal failure during MRA treatment for >7 consecutive days, leading to permanent discontinuation of the MRA treatment
- •16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotrophin urine or serum test
- •17. Known hypersensitivity to the study intervention (active substance or excipients)
- •18. Hepatic insufficiency classified as Child-Pugh C at screening or randomization
- •19. Addison’s disease
- •20. Requirement of any IV vasodilating drug (e.g. nitrates, nitroprusside), any IV natriuretic peptide (e.g. nesiritide, carperitide), any IV positive inotropic agents, or mechanical support (intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, or any ventricular assist device) within 24 hours prior to randomization
- •21. Participants who require treatment with more than one ACEI, ARB or angiotensin-receptor neprilysin inhibitor (ARNI), or two simultaneously at randomization
- •22. Continuous (at least 90 days) treatment with an MRA (e.g. spironolactone, eplerenone, canrenone, esaxerenone) within 12 months prior to screening. Last intake at least 30 days before randomization. Trea
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