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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
Sponsor:
Information provided by (Responsible Party):
Abdelrahman Ali Elbraky, Ain Shams University

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 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

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sildenafil 25
Twenty hemodialysis patients will receive a dose of 25mg sildenafil daily for 3 months.
Drug: Sildenafil
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.
Drug: Sildenafil
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.
Other: Placebo
Placebo tablet.




Primary Outcome Measures :
  1. Decrease in Pulmonary Artery Pressure [ Time Frame: 3 months ]
    Decrease in ePAP (mmHg) via Doppler echocardiography Systolic right ventricular (or pulmonary artery)


Secondary Outcome Measures :
  1. Transthoracic echocardiography [ Time Frame: 3 months ]
    Decrease in Estimated PASP (Pulmonary Artery Systolic Pressure) in (mmHg).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

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


Locations
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Egypt
Ain Shams University Hospital
Cairo, Abbasia, Egypt, 00202
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Director: Tamer W Elsaid, MD Associate Professor of Internal Medicine and Nephrology

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Responsible Party: Abdelrahman Ali Elbraky, Assistant lecturer of Internal Medicine and Nephrology, Ain Shams University
ClinicalTrials.gov Identifier: NCT03763045     History of Changes
Other Study ID Numbers: Med135
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents