EUCTR2015-004402-42-IT进行中（未招募）1 期
A pilot study assessing the effects of Ranolazine on coronary microvascular dysfunction in patients with hypertrophic cardiomyopathy - Ranolazine microvascular dysfunction HCM
OSPEDALE SAN RAFFAELE0 个研究点目标入组 24 人开始时间: 2021年9月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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.Male and female gender.
- •2.Patients who fulfil conventional echocardiographic criteria for the diagnosis of HCM: maximum LV wall thickness = 15 mm;
- •3.Patients aged > 18 years and < 80 years;
- •4.Absence of severe resting LV outflow tract obstruction (peak gradient = 50 mmHg);
- •5.Sinus rhythm; accepted isolated Supraventricular and Ventricular Premature Beats (VPB);
- •6.Females of childbearing potential must be using highly effective contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner);
- •7.Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test;
- •8.Ability to give 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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1.severe resting LV outflow tract obstruction (peak gradient > 50 mmHg)
- •2.Females of childbearing potential not using highly effective contraception;
- •3.Presence of known coronary artery disease (CAD);
- •4.Presence of Chronic Obstructive Airways Disease;
- •6.Other causes of microvascular dysfunction including long-standing history of arterial hypertension, diabetes, uncontrolled dyslipidemia;
- •7.Body mass index >32 kg/m2; < 17 kg/m2
- •8.Overt LV systolic dysfunction with end-stage progression (LV-EF <50%);
- •9.Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone);
- •10.Patients treated with sotalol, dronedarone, class I antiarrhythmics or other QT-prolonging drugs; stable treatment with amiodarone is permitted;
- •11.Patients with QTc (Bazett’s formula) at baseline = 450 ms males; = 470 msec females
- •12.Any clinically relevant haematological or biochemical abnormality on routine screening, according to Investigator’s judgment;
- •13.Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.);
- •14.Severe renal impairment defined as GFR < 29 mL/min/1.73 m2 or creatinine level > 2.5 mg/dL or BUN >60 mg/dL;
- •15.Moderate or severe hepatic impairment or hepatic insufficiency defined as SGOT or SGPT > 2 times greater than upper limit of normal of the local laboratory or total serum bilirubin > 1.5 times greater than normal upper limit of the local laboratory;
- •16.Dementia, psychosis, alcoholism (>350 g ethanol/week) or chronic abuse of medicaments, drugs or psychoactive substances;
- •17.Claustrophobia;
- •18.Females who are pregnant or lactating;
- •19.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;
- •20.Risk of poor patient cooperation;
- •21.Participation into a clinical study = 2 months before enrolment;
- •22.Inability or unwillingness to issue the informed consent;
- •23.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);
- •24.Concomitant use of Atorvastatin (>80 mg daily);
- •25.Concomitant use of >1000 mg daily dose of metformin during the study.
研究者
相似试验
招募中
2 期
Evaluation of the effect of Ranolazine on patients with slow flow coronary arteriesIRCT20220516054874N6Mashhad University of Medical Sciences48
招募中
2 期
Prevention of gastrointestinal bleeding and ventilator-associated pneumonia in children under mechanical ventilation.Condition 1: Gastrointestinal bleeding. Condition 2: Ventilator-associated pneumonia.Other agents primarily affecting the gastrointestinal systemInterstitial pulmonary disease, unspecifiedT47.8J84.9IRCT20190522043672N1Mashhad University of Medical Sciences87
尚未招募
3 期
Role of Rasontail matra basti in Anovulatory cycleCTRI/2020/12/030096swati pathade
尚未招募
2 期
Treatment of Abnormal Vaginal Discharge by giving Vaginal Wash.CTRI/2023/09/057996Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Thanniruhalla BMRoad Hassan
招募中
3 期
Ranolazine effects on angina pectoris in patients with coronary artery bridgeMyocardial bridge in coronary arteries.Malformation of coronary vesselsQ24.5IRCT20230801059005N2Shiraz University of Medical Sciences52