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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
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.
Secondary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sildenafil 25 | Experimental | Twenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months. |
|
| Sildenafil 50 | Experimental | Twenty hemodialysis patients will receive a dose of 50mg sildenafil daily for 3 months. |
|
| Placebo | Placebo Comparator | Twenty hemodialysis patients will receive a placebo tablet daily for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil | Drug | Sildenafil 25 mg: Phosphodiesterase inhibitor to be taken once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in Pulmonary Artery Pressure | Decrease in ePAP (mmHg) via Doppler echocardiography Systolic right ventricular (or pulmonary artery) | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Transthoracic echocardiography | Decrease in Estimated PASP (Pulmonary Artery Systolic Pressure) in (mmHg). | 3 months |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Tamer W Elsaid, MD | Associate Professor of Internal Medicine and Nephrology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Hospital | Cairo | Abbasia | 00202 | Egypt |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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Sildenafil 25: Twenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months.
Sildenafil 50: Twenty hemodialysis patients will receive a dose of 50mg sildenafil daily for 3 months.
Placebo: Twenty hemodialysis patients will receive a placebo tablet daily for 3 months.
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Double Blinded
| Sildenafil |
| Drug |
Sildenafil 50 mg: Phosphodiesterase inhibitor to be taken once daily |
|
| Placebo | Other | Placebo tablet. |
|
| D002318 |
| Cardiovascular Diseases |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |