NCT01324999已完成2 期
Tadalafil for Sarcoidosis Associated Pulmonary Hypertension
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- 6 Minute Walk Distance
研究概览
简要总结
This study is designed to assess safety and efficacy of tadalafil in patients with Sarcoidosis Associated Pulmonary Hypertension.
Hypothesis: Tadalafil is safe and effective in treating pulmonary hypertension in patients with Sarcoidosis
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
- •Biopsy proven sarcoidosis
- •Mean pulmonary artery pressure > 25 mmHg at rest or greater than 30 mmHg with exercise by right heart catheterization within 1 year prior to entry into study
- •Pulmonary capillary wedge pressure ≤ 15 mmHg
- •PVR values ≥ 3.0 Woods units
- •Forced vital capacity (FVC) > 40% predicted
- •Forced expiratory volume in 1 second (FEV1) > 40% predicted
- •WHO functional class II or III
- •Stable sarcoidosis treatment regimen for three months prior to entry into study
- •6 minute walk distance between 150-450 meters
- •Stable dose of antihypertensive medications
- •On no other medication to treat PAH (sildenafil, vardenafil, treprostinil, epoprostenol, iloprost, bosentan, ambrisentan) within one month prior to enrollment and during duration of the study
- •Non-pregnant females
排除标准
- •Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
- •Severe systemic hypertension > 170/95
- •Severe systemic hypotension < 90/50
- •History of priapism
- •Patients with congestive heart failure (left ventricular dysfunction) LVEF < 45% by echocardiogram
- •Anticipation by the investigator for escalation in sarcoidosis treatment during the course of the study
- •Pulmonary hypertension related to etiology other than sarcoidosis (i.e. HIV, scleroderma, chronic thromboemboli)
- •Use within 1 month of an sildenafil or vardenafil
- •WHO functional class IV status
- •Patients with severe other organ disease felt by investigators to impact on survival during the course of the study
- •Subjects with liver function abnormalities (ALT or AST > 3 times the upper limit of normal at screening or at baseline) or chronic liver disease
- •Advanced kidney failure (GFR < 30 ml/min at screening or at baseline)
- •History of hypersensitivity reaction or adverse effect related to tadalafil
- •Pregnant or lactating women
- •Concomitant use of nitrates (any form) either regularly or intermittently
- •Concomitant use of potent CYP3A inhibitors (eg, ritonavir, ketoconazole, itraconazole)
- •Any additional contraindications and precautions specified in the package inserts for Tadalafil (Adcirca) not listed above
研究组 & 干预措施
Sarcoid Associated Pulm. Hypertension
Experimental
Single-arm open-label proof of concept study of tadalafil in patients with sarcoidosis associated pulmonary hypertension.
干预措施: Tadalafil (Drug)
结局指标
主要结局
6 Minute Walk Distance
时间窗: Baseline, Week 8, Week 16, Week 24
次要结局
- Resting Oxygen Saturation(Baseline, Week 24)
- Short Form-36 Global Score(Baseline, Week 8, Week 16, Week 24)
- St. George's Respiratory Questionnaire (SGRQ) Score(Baseline, Week 8, Week 16, Week 24)
- Number of Participants With Change in WHO Functional Class (WHO FC)(Baseline, Week 24)
- Brain Natriuretic Peptide Level(Baseline, Week 8, Week 16, Week 24)
- Oxygen Desaturation During 6 Minute Walk Test(Baseline, Week 24)
- Maximum Borg Dyspnea Score During 6 Minute Walk Test(Baseline, Week 8, Week 16, Week 24)
研究者
H. James Ford, MD
Assistant Professor of Medicine
University of North Carolina, Chapel Hill
研究点 (2)
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