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

NCT01481350 | Completed Phase 2

• 1 other identifier: 0064280
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• reduced mechanical ventilation

  The primary outcome is the reduction of time on mechanical ventilation

  seven days

Secondary Outcomes (1)

• ICU length of stay

  28 days

Study Arms (1)

Sildenafil

EXPERIMENTAL

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

Interventions

sildenafil DRUG

The patients will receive a dose of 10 mg every 8 hours, for a maximum time of 72 hours.

Sildenafil

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

San Giovanni Battista Hospital University of Turin

Turin, Turin, 10126, Italy

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

• Mauro Rinaldi, MD

  San Giovanni Battista, Hospital University of Turin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: November 25, 2011
• First Posted: November 29, 2011
• Study Start: February 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

IT (1)