Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Absolute Change in Right Ventricular Ejection Fraction
研究概览
简要总结
The purpose of this study is to determine whether carvedilol treatment of patients with pulmonary arterial hypertension and associated right heart failure is safe and results in an improved function of the right heart.
详细描述
Patients with pulmonary arterial hypertension (PAH) will be treated with carvedilol for 24 weeks. During this time, carvedilol will be titrated from an initial dose of 3.125mg BID to a maximal dose of 25mg BID. At the start and end of the study, we will obtain cardiac MRI, 6 minute walk distance, brain natriuretic peptide (serum), echocardiogram, and functional class assessment. Our primary outcome is a change in right ventricular ejection fraction with cardiac MRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •idiopathic, familial or associated PAH, WHO group 1
- •NYHA class II or III
- •clinically stable with optimized PAH treatment for at least 3 months
- •no or minimal evidence of fluid overload or volume depletion, with or without diuretic treatment
- •age > 18 years
- •mean pulmonary artery pressure (mPAP) > 25 mmHg
- •6 minute walk distance (6MWD) over 100m
排除标准
- •Structural heart disease unrelated to PAH
- •Recent (<3 months) treatment with an intravenous positive inotropic agent
- •current use of β-blockers
- •history of reactive airways disease
- •history of adverse reaction to β-blockers
- •heart block on ECG or resting heart rate < 60 bpm
- •cardiac index < 1.8 l/min/m2
- •systemic hypotension (systolic pressure < 90 mmHg)
- •pulmonary capillary wedge pressure > 15 mmHg
- •inability to give informed consent
- •contraindications to CT and/or PET scanning
- •coagulopathy (INR>1.5 or platelet count<50000/mm3)
- •severe renal insufficiency (creatinine clearance <30 ml/min/m2)
- •malignancy or any co-morbidity limiting survival or conditions predicting inability to complete the study.
研究组 & 干预措施
carvedilol
Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
干预措施: Carvedilol (Drug)
结局指标
主要结局
Absolute Change in Right Ventricular Ejection Fraction
时间窗: baseline, 6 months
Change in right ventricular ejection fraction is measured by cardiac magnetic resonance imaging, using the method of disks with the reading radiologist being blinded to before and after images. Cardiac magnetic resonance imaging was done at baseline and 6 months only
次要结局
- Change in Right Ventricular End Systolic Volume(baseline and 6 months)
- Change in 6 Minute Walk Distance(baseline and 6 months)
- Change in Tricuspid Annular Plane Systolic Excursion(baseline and 6 months)