Sildenafil for Post-capillary Pulmonary Hypertension in Patients Undergoing Cardiac Surgery

Study Overview
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Brief Summary
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Pulmonary hypertension increases the perioperative risk in patients undergoing cardiac surgery for valvular heart diseases, especially in patients with a long life mitral valve disease. The present study wants to test the hypothesis that intravenous administration of sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle.

Detailed Description
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Pulmonary hypertension represents an increased risk for perioperative patients undergoing cardiac surgery for valvular heart disease especially in patients with a long life mitral valve disease complicated by sever pulmonary hypertension, with high risk of developing post operative right ventricular failure during separation from cardiopulmonary by pass. A recent study showed that a single oral administration of sildenafil at the beginning of the cardiac intervention in patients undergoing valvular heart surgery complicated by pulmonary hypertension reduces pulmonary vascular resistances without inducing significant effects on systemic vascular resistances. The present study wants to test the hypothesis that intravenous administration of sildenafil reduces pulmonary vascular resistances and afterload of the right ventricle avoiding right ventricular failure. This should support weaning from cardiopulmonary by pass in patients undergoing cardiac surgery for valvular heart diseases associated to pulmonary hypertension.

Official Title
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Phase 2 Use of Sildenafil for the Treatment of Post-capillary Hypertension in Patients Undergoing Cardiac Surgery

Conditions
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Pulmonary Hypertension

Intervention / Treatment
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* Drug: sildenafil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients undergoing valvular heart surgery associated to post capillary pulmonary hypertension with a mean pulmonary arterial pressure (mPAP)>30mmHg or pulmonary vascular resistance (PVR)>3Wu. Exclusion Criteria: patients younger than 18 years old ischemic cardiomyopathy Ejection Fraction (EF)<30% severe Chronic obstructive pulmonary disease (COPD) with oxygen and bronchodilators therapy chronic pulmonary disease, chronic renal failure on dialysis hepatic failure patients with orotracheal intubation and already admitted to the ICU before the intervention

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sildenafil<br>All patient will be treat with a intravenous administration of the drug from the beginning of the intervention, for a maximum of 72 hours. | Drug: sildenafil<br>* The patients will receive a dose of 10 mg every 8 hours, for a maximum time of 72 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduced mechanical ventilation | The primary outcome is the reduction of time on mechanical ventilation | seven days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU length of stay | The secondary outcome is to evaluate the reduction of intensive care unit length of stay. | 28 days |