Status:
UNKNOWN
Sildenafil in Hemodialysis Patients With Pulmonary Hypertension
Lead Sponsor:
Ain Shams University
Conditions:
Pulmonary Hypertension
Hemodialysis Complication
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
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 hypertens...
Detailed Description
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 estima...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
December 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2019
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03763045
Start Date
December 2 2018
End Date
February 28 2019
Last Update
January 9 2019
Active Locations (1)
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1
Ain Shams University Hospital
Cairo, Abbasia, Egypt, 00202