Sildenafil in Hemodialysis Patients With Pulmonary Hypertension

NCT03763045 | Unknown Phase 2 DMC

• 1 other identifier: Med135
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Pulmonary Hypertension; Hemodialysis Complication

Outcome Measures

Primary Outcomes (1)

• Decrease in Pulmonary Artery Pressure

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

  3 months

Secondary Outcomes (1)

• Transthoracic echocardiography

  3 months

Study Arms (3)

Sildenafil 25

EXPERIMENTAL

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

Drug: Sildenafil

Sildenafil 50

EXPERIMENTAL

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

Drug: Sildenafil

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Sildenafil DRUG

Sildenafil 25 mg: Phosphodiesterase inhibitor to be taken once daily

Sildenafil 25

Placebo OTHER

Placebo tablet.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Current treatment of pulmonary hypertension (prostacyclin analogues, endothelin receptor antagonists or phosphodiesterase inhibitors).
• Heart diseases (congestive heart failure, ischemic heart disease, congenital heart disease).
• Lung diseases (chronic obstructive pulmonary disease, pulmonary thromboemboli or tumor, interstitial lung diseases, sleep apnea, pulmonary fibrosis, Sarcoidosis).
• Systemic diseases (scleroderma, systemic lupus erythematosus, portal hypertension).
• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, Abbasia, 00202, Egypt

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tamer W Elsaid, MD

  Associate Professor of Internal Medicine and Nephrology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Internal Medicine and Nephrology

Model Details: 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.

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: December 4, 2018
• Study Start: December 2, 2018
• Primary Completion: February 16, 2019
• Study Completion: February 28, 2019
• Last Updated: January 9, 2019

Record last verified: 2019-01

Locations

EG (1)