NCT01839110已完成4 期
A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Effect of Ranolazine on Outcomes in Subjects With Pulmonary Hypertension and Right Ventricular Dysfunction Accompanied by a Comparative Study of Cellular Metabolism in Subjects With Pulmonary Hypertension With and Without Right Ventricular Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- Changes in Right Ventricular Ejection Fraction
研究概览
简要总结
This study is looking to see if giving ranolazine to subjects on stable pulmonary hypertension specific therapies but with right ventricular dysfunction (RVEF <45%) would improve their outcome. This study is accompanied by a baseline comparison of the metabolic profiling/microRNA/iPS cells of subjects with and without right ventricular dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic pulmonary hypertension based on one of the following criteria: Idiopathic pulmonary arterial hypertension, Familial pulmonary arterial hypertension, pulmonary hypertension associated with connective tissue disease, chronic thromboembolic pulmonary hypertension-nonsurgical/distal vessel disease or patients who are reluctant to go to surgery within a 6-month period and are willing to participate, simple congenital such as repaired atrial septal defect or ventricular septal defect or unrepaired small atrial septal defect or ventricular septal defect with persistent and out of proportion pulmonary arterial hypertension, group 3 patients who have a component of pulmonary arterial hypertension, pulmonary arterial hypertension caused by conditions affect the veins and small vessels of the lungs, sickle cell disease, group 5 pulmonary hypertension such as polycythemia vera, essential thrombocythemia, sarcoidosis, or vasculitis, or metabolic disorder.
- •WHO functional class II, III, or IV
- •Mean pulmonary artery pressure >25 mmHg at rest
- •Pulmonary capillary wedge pressure or left ventricular end diastolic pressure < 15 mmHg
- •Baseline 6-minute walk test distance > 50 meters
- •Stable on baseline existing PH specific therapy for 12 weeks with no dosage change within 28 days prior to screening.
排除标准
- •Previous treatment with or prior sensitivity to ranolazine
- •Any family history of corrected QT interval prolongation, congenital long QT syndrome, or receiving drugs that prolong the corrected QT interval
- •Parenchymal lung disease showing total lung capacity < 50% of predicted OR forced expiratory volume at one second/forced vital capacity < 50%
- •Portal hypertension associated with liver disease
- •Left sided heart disease including any of the following: moderate or greater aortic or mitral valve disease, Any left ventricle cardiomyopathy, Left ventricular systolic dysfunction defined as an ejection fraction < 50%, Symptomatic coronary artery disease
- •Uncontrolled hypertension
- •Uncontrolled diabetes
研究组 & 干预措施
Ranolazine
Active Comparator
Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day
干预措施: Ranolazine (Drug)
Placebo
Placebo Comparator
Placebo by mouth twice per day
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in Right Ventricular Ejection Fraction
时间窗: 6 months
right ventricular ejection fraction by cardiac MRI
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
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