NCT03763045

Sildenafil in Hemodialysis Patients With Pulmonary Hypertension

Evaluation of the Effect of Sildenafil in Hemodialysis Patients With Pulmonary Hypertension

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 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

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 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.

Conditions

• Pulmonary Hypertension
• Hemodialysis Complication

Interventions

Type	Name	Description
DRUG	Sildenafil	Sildenafil 25 mg: Phosphodiesterase inhibitor to be taken once daily
DRUG	Sildenafil	Sildenafil 50 mg: Phosphodiesterase inhibitor to be taken once daily
OTHER	Placebo	Placebo tablet.

Timeline

• Start date: 2018-12-02
• Primary completion: 2019-02-16
• Completion: 2019-02-28
• First posted: 2018-12-04
• Last updated: 2019-01-09

Locations

1 site across 1 country: Egypt