Sildenafil in Hemodialysis Patients With Pulmonary Hypertension

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Age from 18-80 years old. 2. 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. 3. Estimated Pulmonary Artery Pressure (ePAP) ≥35 mmHg via Doppler echocardiography. 4. Urea reduction ratio (URR) will be ≥ 60% for all patients. 5. Dry weight will be targeted in each case to achieve edema-free state. 6. Informed consent in accordance with the Declaration of Helsinki.

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03763045
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2/Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ain Shams University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Tamer W Elsaid, MD
Principal Investigator Affiliation Associate Professor of Internal Medicine and Nephrology
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Active, not recruiting
Countries Egypt
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Hypertension, Hemodialysis Complication
Additional Details

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.

Arms & Interventions

Arms

Experimental: Sildenafil 25

Twenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months.

Experimental: Sildenafil 50

Twenty hemodialysis patients will receive a dose of 50mg sildenafil daily for 3 months.

Placebo Comparator: Placebo

Twenty hemodialysis patients will receive a placebo tablet daily for 3 months.

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.

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International Sites

Ain Shams University Hospital, Cairo, Abbasia, Egypt

Status

Address

Ain Shams University Hospital

Cairo, Abbasia, 00202

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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