EUCTR2011-004507-20-DE进行中（未招募）不适用
RANOLAZINE IN PATIENTS WITH SYMPTOMATIC HYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDY ASSESSING THE EFFECTS ON EXERCISE CAPACITY, DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS (RESTYLE- HCM STUDY) - RESTYLE- HCM STUDY
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •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:
- •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)
- •Concomitant use of > 1000 mg daily dose of metformin during the study
- •Concomitant use of >20 mg daily dose of Simvastatin during the study (in case of patients taking simvastatin >20 mg daily, the switch to other statins not metabolized by the CYP3A4 could be considered).
- •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/minor 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
- •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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