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Sildenafil in Hemodialysis Patients With Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension, Hemodialysis Complication

Status

Unknown status

Phase

Phase 2

Locations

Egypt

Study Type

Interventional

Intervention

Sildenafil

Placebo

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age from 18-80 years old.
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.
Estimated Pulmonary Artery Pressure (ePAP) ≥35 mmHg via Doppler echocardiography
Urea reduction ratio (URR) will be ≥ 60% for all patients.
Dry weight will be targeted in each case to achieve edema-free state.
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

Sites / Locations

Ain Shams University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Sildenafil 25

Sildenafil 50

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Decrease in Pulmonary Artery Pressure

Decrease in ePAP (mmHg) via Doppler echocardiography Systolic right ventricular (or pulmonary artery)

Secondary Outcome Measures

Transthoracic echocardiography

Decrease in Estimated PASP (Pulmonary Artery Systolic Pressure) in (mmHg).

Full Information

NCT ID

NCT03763045

First Posted

November 7, 2018

Last Updated

January 8, 2019

Sponsor

Ain Shams University

1. Study Identification

Unique Protocol Identification Number

NCT03763045

Brief Title

Sildenafil in Hemodialysis Patients With Pulmonary Hypertension

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

December 2, 2018 (Actual)

Primary Completion Date

February 16, 2019 (Anticipated)

Study Completion Date

February 28, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

1- To evaluate the effect of sildenafil on pulmonary artery pressure and right ventricular function in hemodialysis patients with pulmonary hypertension. Primary outcome: ● Reduction in estimated Pulmonary Artery pressure value (ePAP) in mmHg via transthoracic Doppler Echocardiography. Secondary outcomes: Detection of safety of sildenafil in hemodialysis patients. Finding out sildenafil's optimum dose for hemodialysis patients with pulmonary hypertension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Hypertension, Hemodialysis Complication

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

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

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double Blinded

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sildenafil 25

Arm Type

Experimental

Arm Description

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

Arm Title

Sildenafil 50

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sildenafil

Intervention Description

Sildenafil 25 mg: Phosphodiesterase inhibitor to be taken once daily

Intervention Type

Drug

Intervention Name(s)

Sildenafil

Intervention Description

Sildenafil 50 mg: Phosphodiesterase inhibitor to be taken once daily

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Placebo tablet.

Primary Outcome Measure Information:

Title

Decrease in Pulmonary Artery Pressure

Description

Decrease in ePAP (mmHg) via Doppler echocardiography Systolic right ventricular (or pulmonary artery)

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Transthoracic echocardiography

Description

Decrease in Estimated PASP (Pulmonary Artery Systolic Pressure) in (mmHg).

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age from 18-80 years old. 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. Estimated Pulmonary Artery Pressure (ePAP) ≥35 mmHg via Doppler echocardiography Urea reduction ratio (URR) will be ≥ 60% for all patients. Dry weight will be targeted in each case to achieve edema-free state. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tamer W Elsaid, MD

Organizational Affiliation

Associate Professor of Internal Medicine and Nephrology

Official's Role

Study Director

Facility Information:

Facility Name

Ain Shams University Hospital

City

Cairo

State/Province

Abbasia

ZIP/Postal Code

00202

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Sildenafil in Hemodialysis Patients With Pulmonary Hypertension

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