EUCTR2011-000805-27-GB进行中（未招募）1 期
Effect of Ranolazine in Heart Failure Patients with Preserved Ejection Fraction - ERIPE
Menarini International Operations Luxembourg S.A., Avenue de la Gare, 1611 Luxembourg, Luxembourg0 个研究点目标入组 4 人开始时间: 2012年4月19日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4
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
入选标准
- •1.Male or female between the ages of 40 to 85 years, inclusive
- •2.Heart failure with preserved EF defined by the following:
- •a.Signs or symptoms of HF (previous documented hospitalization for HF, decompensation in the last 12 months, or exertional dyspnea or fatigue, New York Heart Association [NYHA] Class II-IV with or without clinical signs of HF)
- •b.LVEF > 45% measured by echocardiogram
- •c.NT-ProBNP > 200 pg/ml or BNP > 80 pg/ml
- •d.Evidence of LV diastolic dysfunction or increased LV filling pressure documented in the last month and defined by the following:
- •LV end diastolic pressure > 16 mmHg
- •or E/E’ > 15 (septal annular velocity)
- •or E/E’ between 8 and 15 and at least one of the following:
- •–Plasma brain natriuretic peptide (BNP) > 150 pg/ ml or plasma N terminal pro b-type natriuretic peptide (NT proBNP) > 450 pg/ml
- •–Ratio of early (E) to late (A) mitral valve flow velocity (E/A) < 0.5 and mitral flow deceleration time (DT E) > 280 ms
- •–LV atrial area > 25 cm² (apical 4 chamber)
- •–LV posterior wall thickness > 12 mm
- •e.Sinus rhythm
- •3.Written informed consent
- •4.6MWT distance = 450 meters and = 100 meters at screening
- •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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1.Unstable situation for acute acute coronary syndrome, or worsening angina in the last 3 months
- •2. Unstable situation for acute heart failure in the last month
- •3.Poor echogenicity
- •4.Significant chronic lung disease (e.g., chronic obstructive pulmonary disease, asthma), prior hospitalization for acute exacerbation, home oxygen use, chronic inhaled or systemic steroid therapy
- •5.Documented hypertrophic or restrictive cardiomyopathy
- •6.Body mass index (BMI) = 30 kg/m2
- •7.Tricuspid Rigurgitation Max Velocity > 4m/s
- •8.Previous Heart Failure hospitalization or decompensation, with documented LV Systolic Dysfunction (LVEF = 45%)
- •9.Sustained atrial fibrillation or flutter in the previous 3 months
- •10.Change in cardiovascular medication during the last 4 weeks
- •11.Change in diuretic medication during the last 2 weeks
- •12.Revascularization within the last 3 months
- •13.Second- or third-degree atrioventricular (AV) block
- •14.Severe and uncontrolled hypertension stage 3 (systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg)
- •15.Significant valvular disease: moderate or severe mitral or aortic valve disease
- •16.Severe renal impairment (creatinine clearance < 30 ml/min)
- •17.Moderate or severe hepatic impairment (Child-Pugh Class A or Class B)
- •18.Previous cardiac surgery
- •19.Inability to perform the 6MWT
- •20.6MWT distance > 450 meters or < 100 meters at screening
- •21.Screening and baseline 6-minute walk distance (6MWD) with >10% variability
- •22.Stroke within the last 3 months
- •23.Implantable pacemaker for chronotropic incompetence, cardioverter defibrillator, or LV assist device
- •24.Prior heart transplantation
- •25.Current treatment with potent inhibitors of CYP3A, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, and saquinavir
- •26.Current treatment with CYP3A inducers, such as rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and St. John’s wort
- •27.Concomitant administration of Class Ia (e.g., quinidine) or Class III (e.g., dofetilide, sotalol) antiarrhythmics other than amiodarone
- •28.Use of greater than 1000mg daily dose of metformin during the study
- •29.Prior treatment with ranolazine
- •30.Hypersensitivity to the active substance or to any of the excipients
- •31.Participation in another trial of an investigational drug or device within 30 days prior to screening
- •32.Pregnant or breast-feeding
- •33.Severe psychiatric disorders/neurological disorders
- •34.Abuse of alcohol, analgesics, or psychotropic drugs
- •35.Disabling or terminal illness
- •36.Inability or unwillingness, in the Investigator’s opinion, to follow study procedures
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