Sildenafil in Hemodialysis Patients With Pulmonary Hypertension
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|ClinicalTrials.gov Identifier: NCT03763045|
Recruitment Status : Active, not recruiting
First Posted : December 4, 2018
Last Update Posted : January 9, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension Hemodialysis Complication||Drug: Sildenafil Other: Placebo||Phase 2 Phase 3|
1- To evaluate the effect of sildenafil on pulmonary artery pressure and right ventricular function in hemodialysis patients with pulmonary hypertension.
● Reduction in estimated Pulmonary Artery pressure value (ePAP) in mmHg via transthoracic Doppler Echocardiography.
- Detection of safety of sildenafil in hemodialysis patients.
- Finding out sildenafil's optimum dose for hemodialysis patients with pulmonary hypertension.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
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.
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double Blinded|
|Official Title:||Evaluation of the Effect of Sildenafil in Hemodialysis Patients With Pulmonary Hypertension|
|Actual Study Start Date :||December 2, 2018|
|Estimated Primary Completion Date :||February 16, 2019|
|Estimated Study Completion Date :||February 28, 2019|
Experimental: Sildenafil 25
Twenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months.
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.
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.
- Decrease in Pulmonary Artery Pressure [ Time Frame: 3 months ]Decrease in ePAP (mmHg) via Doppler echocardiography Systolic right ventricular (or pulmonary artery)
- Transthoracic echocardiography [ Time Frame: 3 months ]Decrease in Estimated PASP (Pulmonary Artery Systolic Pressure) in (mmHg).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763045
|Ain Shams University Hospital|
|Cairo, Abbasia, Egypt, 00202|
|Study Director:||Tamer W Elsaid, MD||Associate Professor of Internal Medicine and Nephrology|