Evaluation of the Effect of Sildenafil in Hemodialysis Patients With Pulmonary Hypertension
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Decrease in Pulmonary Artery Pressure
研究概览
简要总结
Sildenafil is a phosphodiesterase inhibitor that can exert a nitric oxide-mediated vasodilation effect, so it's considered one of the preferred agents especially in hypoxia induced pulmonary hypertension, can achieve pulmonary vasodilation by enhancing sustained levels of cyclic guanosine monophosphate (cGMP) and nitric oxide.
Despite the potential burden of pulmonary hypertension in hemodialysis patients, such agent like sildenafil has limited studies about optimum dose, safety and long term efficacy in End stage renal disease patients on hemodialysis with pulmonary hypertension
详细描述
1- To evaluate the effect of sildenafil on pulmonary artery pressure and right ventricular function in hemodialysis patients with pulmonary hypertension.
- Primary outcome:
● Reduction in estimated Pulmonary Artery pressure value (ePAP) in mmHg via transthoracic Doppler Echocardiography. 2. Secondary outcomes:
- Detection of safety of sildenafil in hemodialysis patients.
- Finding out sildenafil's optimum dose for hemodialysis patients with pulmonary 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double Blinded
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
- •Age from 18-80 years old.
- •Patients on maintenance hemodialysis for more than six months receiving 3 sessions / week using bicarbonate dialysate with a low flux filter and heparin as anticoagulant.
- •Estimated Pulmonary Artery Pressure (ePAP) ≥35 mmHg via Doppler echocardiography
- •Urea reduction ratio (URR) will be ≥ 60% for all patients.
- •Dry weight will be targeted in each case to achieve edema-free state.
- •Informed consent in accordance with the Declaration of Helsinki.
排除标准
- •Current treatment of pulmonary hypertension (prostacyclin analogues, endothelin receptor antagonists or phosphodiesterase inhibitors).
- •2-Heart diseases (congestive heart failure, ischemic heart disease, congenital heart disease).
- •3- Lung diseases (chronic obstructive pulmonary disease, pulmonary thromboemboli or tumor, interstitial lung diseases, sleep apnea, pulmonary fibrosis, Sarcoidosis).
- •4-Systemic diseases (scleroderma, systemic lupus erythematosus, portal hypertension).
- •5-Human immunodeficiency virus (HIV) infection. 6-History of hypersensitivity to sildenafil. 7-Treatment with any drugs that may interact with sildenafil (Erythromycin , Azoles, Saquinavir-CYP3A4 inhibitors- , Bosentan - CYP3A4 inducer-Nitrates ) 8- Uncontrolled hypertension 9- Anemia with hemoglobin level <10 g/dl
研究组 & 干预措施
Sildenafil 25
Twenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months.
干预措施: Sildenafil (Drug)
Sildenafil 50
Twenty hemodialysis patients will receive a dose of 50mg sildenafil daily for 3 months.
干预措施: Sildenafil (Drug)
Placebo
Twenty hemodialysis patients will receive a placebo tablet daily for 3 months.
干预措施: Placebo (Other)
结局指标
主要结局
Decrease in Pulmonary Artery Pressure
时间窗: 3 months
Decrease in ePAP (mmHg) via Doppler echocardiography Systolic right ventricular (or pulmonary artery)
次要结局
- Transthoracic echocardiography(3 months)
研究者
Abdelrahman Ali Elbraky
Assistant lecturer of Internal Medicine and Nephrology
Ain Shams University