RANOLAZINE IN PATIENTS WITH SYMPTOMATICHYPERTROPHIC CARDIOMYOPATHY: A PILOT STUDYASSESSING THE EFFECTS ON EXERCISE CAPACITY,DIASTOLIC FUNCTION AND SYMPTOMATIC STATUS

Menarini International Operations Luxembourg S.A.0 个研究点目标入组 100 人开始时间: 2011年10月13日最近更新: 2015年2月16日

适应症

试验速览

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•? 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.
•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

•? 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. sotalol) antiarrhythmics other than amiodarone, or other QT-prolonging drugs;
•? 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; BUN >60 mg/dL;
•? 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 (>350 g ethanol/week) 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.

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