Sildenafil in Hemodialysis Patients With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03763045
• Other study ID #: Med135
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: December 2, 2018
• Est. completion date: February 28, 2019

Study information

• Verified date: January 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: February 28, 2019
• Est. primary completion date: February 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis Complication
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Sildenafil
Sildenafil 25 mg: Phosphodiesterase inhibitor to be taken once daily
• Sildenafil
Sildenafil 50 mg: Phosphodiesterase inhibitor to be taken once daily

Other:
• Placebo
Placebo tablet.

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospital	Cairo	Abbasia

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in Pulmonary Artery Pressure	Decrease in ePAP (mmHg) via Doppler echocardiography Systolic right ventricular (or pulmonary artery)	3 months
Secondary	Transthoracic echocardiography	Decrease in Estimated PASP (Pulmonary Artery Systolic Pressure) in (mmHg).	3 months