EUCTR2011-004507-20-IT进行中（未招募）1 期
RANOLAZINE IN PATIENTS WITH SYMPTOMATIC HYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDY ASSESSING THE EFFECTS ON EXERCISE CAPACITY, DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
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
- •Male and female gender; • Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test (females of childbearing potential must be using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner); • Patients which fulfil conventional echocardiographic criteria for the diagnosis of SHCM: Maximum LV wall thickness >= 1.5 cm; • Patients aged > 18 years; • Patients with exertion symptoms and functional limitation (angina and or HF NYHA II-III); • Presence of sinus rhythm; • Peak V02 < 75% of predicted for age and gender; • Absence of resting LV outflow tract obstruction (peak gradient < 30 mmHg); • Written informed consent prior to enrolment into the study; Persons capable to understand the nature, significance and implications of the clinical trial.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •Females of childbearing potential not using adequate contraceptive precautions; • Females who are pregnant or lactating; • Presence of known coronary artery disease (CAD); • Presence of Chronic Obstructive Airways Disease; • Concomitant administration of potent CYP3A4 inhibitors • Concomitant administration of dronedarone Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone, or other QT-prolonging drugs; Concomitant use of CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, St. John?s Wort) • Patients with QTc at baseline >= 500 ms; • Any clinically relevant haematological or biochemical abnormality on routine screening, according to Investigator`s judgment; • Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.); • Severe renal impairment defined as GFR < 29 mL/min; creatinine level > 2.5 mg/dL; GFR must always be calculated; • Moderate or severe hepatic impairment or hepatic insufficiency defined as SGOT or SGPT > 2 times greater than normal upper limit or total serum bilirubin > 1.5 times greater than normal upper limit; • Dementia, psychosis, alcoholism (>280 g ethanol/week for male or >140 g ethanol/week for female patients) or chronic abuse of medicines, drugs or psychoactive substances; • Conditions which in the Investigator`s opinion may interfere with the study`s execution or due to which the patient should not participate for safety reasons; • Risk of low patient cooperation; • Inability or unwillingness to issue the informed consent; • Inability to perform a cardiopulmonary test; • Lactose intolerance; Hypersensitivity to ranolazine or one of the excipients.
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