Sildenafil in Hemodialysis Patients With Pulmonary Hypertension
Atslēgvārdi
Abstrakts
Apraksts
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.
Datumi
| Pēdējoreiz pārbaudīts: | 12/31/2018 |
| Pirmais iesniegtais: | 11/06/2018 |
| Paredzētā reģistrācija iesniegta: | 11/30/2018 |
| Pirmais izlikts: | 12/03/2018 |
| Pēdējais atjauninājums iesniegts: | 01/07/2019 |
| Pēdējā atjaunināšana ievietota: | 01/08/2019 |
| Faktiskais studiju sākuma datums: | 12/01/2018 |
| Paredzamais primārās pabeigšanas datums: | 02/15/2019 |
| Paredzamais pētījuma pabeigšanas datums: | 02/27/2019 |
Stāvoklis vai slimība
Iejaukšanās / ārstēšana
Drug: Sildenafil 25
Drug: Sildenafil 50
Other: Placebo
Fāze
Roku grupas
| Roka | Iejaukšanās / ārstēšana |
|---|---|
| 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. |
Atbilstības kritēriji
| Vecums, kas piemērots studijām | 18 Years Uz 18 Years |
| Dzimumi, kas ir piemēroti studijām | All |
| Pieņem veselīgus brīvprātīgos | Jā |
| Kritēriji | 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 |
Rezultāts
Primārie rezultāti
1. Decrease in Pulmonary Artery Pressure [3 months]
Sekundārie iznākuma mērījumi
1. Transthoracic echocardiography [3 months]
