EUCTR2016-003653-15-ES进行中（未招募）1 期
A multi-center, double-blind, placebo-controlled Phase 2b study to evaluate the efficacy and safety of macitentan in subjects with heart failure with preserved ejection fraction and pulmonary vascular disease - SERENADE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 142
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. Signs or symptoms of heart failure requiring treatment with at least one oral diuretic (any type)
- •2. LVEF = 40% (by echocardiography at screening)
- •3. NYHA FC II to III
- •4. Subjects with at least one of the following:
- •a. HF hospitalization (defined as HF as the major reason for hospitalization or treatment for HF lasting > 12 hours and/or including i.v. diuretics at a healthcare facility) within 12 months prior to Screening
- •b. Cardiac catheterization performed within 6 months prior to Screening showing end-expiratory PAWP or LVEDP > 15 mmHg
- •c. Patients with structural heart disease defined as either one of the following by echocardiography at Screening:
- •i. Left atrial (LA) enlargement:
- •Left atrial volume (LAV) > 58 ml (male) / > 52 ml (female) or
- •Left atrial volume index (LAVI) = 28 ml/m2, or
- •LA area > 20 cm2, or
- •LA diameter > 4.0 cm (male) / > 3.8 cm (female)
- •ii. Left ventricular septal thickness or posterior wall thickness >= 1.1 cm
- •5. Elevated NT-proBNP / BNP: = 250 / 75 pg/mL for subjects in sinus rhythm or = 1000 / 300 pg/mL for subjects with atrial fibrillation (AF) at any time within 3 months prior to Screening
- •6. Pulmonary vascular disease or RV dysfunction meeting at least one of the following echocardiographic (at screening) and/or right heart catheterization (RHC) parameters (within 6 months prior to Screening):
- •a. Echocardiographic peak TR velocity > 2.8 m/s or invasive mPAP = 25 mmHg or invasive PASP > 40 mmHg (RHC) and evidence of RV dysfunction (TAPSE < 17 mm or RV fractional area change < 35% or RV tissue Doppler s’ velocity < 9.5 cm/s)
- •b. Diastolic Pulmonary Vascular Pressure Gradient (DPG) > 5 mmHg (RHC)
- •c. PVR > 3 Wood Units (RHC)
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •1. Any prior measurement of LVEF < 40%.
- •Cardiovascular comorbidities:
- •2. Significant unrepaired structural valvular heart disease (i.e., greater than mild aortic or mitral stenosis, and greater than moderate aortic or mitral regurgitation).
- •3. Hypertrophic, restrictive, and infiltrative cardiomyopathies.
- •4. Pericardial disease.
- •5. Acute coronary syndrome, including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI) or unstable coronary artery disease or has undergone coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) within 3 months of Screening.
- •6. Known indication for PCI or CABG.
- •7. Uncontrolled heart rate (HR) from atrial fibrillation or atrial flutter (> 110 beats per minute) as assessed by ECG.
- •8. History of serious life-threatening or hemodynamically significant arrhythmias, including symptomatic or sustained ventricular tachycardia or defibrillator shock within 12 month(s) of Screening.
- •9. History of or anticipated heart transplant or anticipated/implanted ventricular assist device.
- •10. Transient ischemic attack (TIA) or stroke within 3 months of Screening.
- •11. Systolic blood pressure (SBP) = 180 mmHg1 or diastolic blood pressure (DBP) = 110 mmHg.
- •Other causes of right heart failure not associated with left ventricular dysfunction:
- •12. Significant parenchymal lung disease fulfilling any of the following:
- •a. Forced expiratory volume in 1 second / forced vital capacity (FEV1/FVC ratio) < 0.7 associated with FEV1 < 50% of predicted value after bronchodilator administration
- •b. Known moderate or severe restrictive lung disease, e.g., total lung capacity (TLC) < 60% (predicted)
- •c. Clinical suspicion of diffuse interstitial fibrosis or alveolitis, unless excluded by high resolution computed tomography (CT)
- •d. Clinical suspicion of pulmonary thromboembolism within 12 months prior to Screening, unless excluded by ventilation/perfusion (V/Q) scan or computed tomography angiography (CTA)
- •13. Severe renal dysfunction with an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula.
- •14. Known and documented severe hepatic impairment, e.g., Child Pugh Class C.
- •15. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) = 3 × the upper limit of normal (ULN) at Screening.
- •16. Hemoglobin < 100g/L (< 10 g/dl) at Screening.
研究者
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