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Sildenafil in Hemodialysis Patients With Pulmonary Hypertension

NCT03763045 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-01-09

No results posted yet for this study

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

Conditions

  • Pulmonary Hypertension
  • Hemodialysis Complication

Interventions

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.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Tamer W Elsaid, MD · Associate Professor of Internal Medicine and Nephrology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-02
Primary Completion
2019-02-16
Completion
2019-02-28

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03763045 on ClinicalTrials.gov