NCT01645826撤回不适用
Calcium Channel Blockers in Nitric Oxide Non-responder Pulmonary Arterial Hypertension.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Six Minute Walk Distance
研究概览
简要总结
The purpose of this study is to determine if cardizem is effective in the treatment of nitric oxide non-responder pulmonary arterial hypertension.
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
- Double (Participant, Investigator)
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
- •Adult participants
- •Confirmed WHO class I pulmonary arterial hypertension
- •Nitric Oxide Non-Responders on right heart catheterization
- •Experience dyspnea, NYHA III-IV with poor oxygenation and quality of life despite standard treatments
- •Must be able to swallow medications
排除标准
- •Pulmonary hypertension secondary to 1) elevations in pulmonary venous pressures (i.e. left heart disease), 2) chronic hypoxemic states from lung diseases such as COPD, sleep-disordered breathing, alveolar hypoventilation disorders, chronic exposure to high altitude and developmental abnormalities 3) chronic thromboembolic disease, 4) sarcoidosis, 5) Lymphangiomyomatosis, 5) Pulmonary Langerhans Cell Histiocytosis
- •Already on a calcium channel blocker
- •Systolic blood pressure less than 90
- •Heart rate less than 55
- •Cannot sign informed consent
- •Right heart failure
- •Pulmonary Veno-occlusive disease
研究组 & 干预措施
Diltiazem
Experimental
The study agent will be Diltiazem and will start at 60 mg po BID then titrated up every two weeks until at a maximum dose of 180mg po BID.
干预措施: Diltiazem Hydrochloride (Drug)
Sugar Pill
Placebo Comparator
The placebo group of patients will be treated with Drug A (sugar pill) PO bid and titrated up every two weeks for next titration dose (actually will be an unchanged concentration).
干预措施: Sugar Pill (Drug)
结局指标
主要结局
Six Minute Walk Distance
时间窗: 12 weeks
次要结局
- Quality of Life Score(12 weeks)
- Pulse Oximetry(12 weeks)
- Dyspnea Score(12 weeks)
研究者
Mark Rumbak
Professor of Medicine, Internal Medicine
University of South Florida
研究点 (1)
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