Sildenafil in Hemodialysis Patients With Pulmonary Hypertension
Ключови думи
Резюме
Описание
1- To evaluate the effect of sildenafil on pulmonary artery pressure and right ventricular function in hemodialysis patients with pulmonary hypertension.
1. 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.
Дати
| Последна проверка: | 12/31/2018 |
| Първо изпратено: | 11/06/2018 |
| Очаквано записване подадено: | 11/30/2018 |
| Първо публикувано: | 12/03/2018 |
| Изпратена последна актуализация: | 01/07/2019 |
| Последна актуализация публикувана: | 01/08/2019 |
| Действителна начална дата на проучването: | 12/01/2018 |
| Приблизителна дата на първично завършване: | 02/15/2019 |
| Очаквана дата на завършване на проучването: | 02/27/2019 |
Състояние или заболяване
Интервенция / лечение
Drug: Sildenafil 25
Drug: Sildenafil 50
Other: Placebo
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Sildenafil 25 Twenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months. | Drug: Sildenafil 25 Sildenafil 25 mg: Phosphodiesterase inhibitor to be taken once daily |
| Experimental: Sildenafil 50 Twenty hemodialysis patients will receive a dose of 50mg sildenafil daily for 3 months. | Drug: Sildenafil 50 Sildenafil 50 mg: Phosphodiesterase inhibitor to be taken once daily |
| Placebo Comparator: Placebo Twenty hemodialysis patients will receive a placebo tablet daily for 3 months. | Other: Placebo Placebo tablet. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: 1. Age from 18-80 years old. 2. 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. 3. Estimated Pulmonary Artery Pressure (ePAP) ≥35 mmHg via Doppler echocardiography 4. Urea reduction ratio (URR) will be ≥ 60% for all patients. 5. Dry weight will be targeted in each case to achieve edema-free state. 6. Informed consent in accordance with the Declaration of Helsinki. Exclusion Criteria: - 1. 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 |
Резултат
Първични изходни мерки
1. Decrease in Pulmonary Artery Pressure [3 months]
Вторични изходни мерки
1. Transthoracic echocardiography [3 months]
