NCT02829034已完成4 期
A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Effect of Ranolazine in Subjects With Pulmonary Hypertension and Right Ventricular Dysfunction Using Cardiovascular MRI
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
- Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage)
研究概览
简要总结
This study is looking to see if giving ranolazine to subjects on stable pulmonary hypertension therapies but with right ventricular dysfunction (RVEF <45%) will improve their health by improving right ventricular (RV) function.
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 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
- •Vasculitis
- •Metabolic disorder
- •World Health Organization 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
- •Pulmonary vascular resistance > 3 mmHg/L/min
- •Right ventricle ejection fraction < 45%
- •6-minute walk test distance > 50 meters
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 chronic 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 systemic hypertension
- •Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any other contraindication to MRI.
研究组 & 干预措施
Ranolazine
Active Comparator
Ranolazine 500mg by mouth twice per day and after two weeks 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
Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage)
时间窗: 26 weeks
Change in right ventricle ejection fraction as assessed by MRI
次要结局
- Percent Change in 6min-walk-test Distance(6 months)
- Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)(6 months)
研究者
研究点 (3)
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