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Does Oral Sildenafil (Viagra) Decrease Mean Pulmonary Artery Pressure After Cardiac Surgery?

This study is currently recruiting participants.
Verified by St. Michael's Hospital, Toronto, May 2008

Sponsors and Collaborators: St. Michael's Hospital, Toronto
University of Toronto
Information provided by: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT00334490
  Purpose

Post-operative pulmonary hypertension is a risk factor for right ventricular failure and an increasing cause of morbidity and mortality in patients undergoing high-risk cardiac surgery. Several treatments have been used to treat and reduce post operative pulmonary hypertension. Unfortunately none of these treatments are approved for use in this condition and only one (inhaled nitric oxide) is specific enough to pulmonary hypertension to not cause dangerous low blood pressure in the rest of the body. Sadly, inhaled nitric oxide is difficult and expensive to use, and can cause lung damage. Sildenafil citrate is quite specific to the lung vessels, is easy to administer and does not easily cause low blood pressure in other areas of the body. We hypothesize that oral sildenafil 12.5mg will decrease the baseline (pre-dose) mPAP by at least 20% compared with a placebo.


Condition Intervention Phase
Pulmonary Hypertension
Drug: Sildenafil (Viagra)
Phase II

Genetics Home Reference related topics:   pulmonary arterial hypertension   

MedlinePlus related topics:   High Blood Pressure    Pulmonary Hypertension   

ChemIDplus related topics:   Sildenafil citrate    Sildenafil   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Phase II, Double Blind Randomized Controlled Trial to Determine the Safety and Efficacy of 12.5mg of Oral Sildenafil (Viagra) Compared to Placebo to Decrease Pulmonary Hypertension in Cardiac Patients After Cardiopulmonary Bypass

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • To determine the efficacy of 12.5mg oral sildenafil to decrease the mPAP in patients presenting with a mPAP >/= 25mmHg after cardiopulmonary bypass.

Secondary Outcome Measures:
  • To determine the efficacy of a second dose of oral sildenafil 12.5mg to decrease the mPAP in those patients who do not respond with a 20% decrease in mPAP after the initial administration of study medication.
  • To determine the safety of oral sildenafil to treat increased mPAP after cardiac surgery.

Estimated Enrollment:   40
Study Start Date:   March 2005
Estimated Study Completion Date:   June 2008

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • 18 years of age or older
  • Scheduled for or has recently undergone a primary or re-do cardiac surgical procedure including coronary artery bypass graft surgery (CABG), heart valve replacement or repair, ascending aortic replacement or repair or any combinations of these procedures with CPB
  • No documented allergy to sildenafil citrate
  • No clinical or laboratory evidence on routine blood work of significant renal disease or failure. (requires dialysis or a creatinine >/= 200umol/L)
  • No clinical or documented laboratory evidence on routine blood work of hepatic disease or failure. (ALT or AST 5x upper limit of normal (ULN) or jaundice)
  • The patient if female and of child bearing age is not known to be pregnant.
  • No documented history of severe chronic respiratory disease defined as an FEV/VC1< 50% predicted.
  • Not currently enrolled as an active participant in another clinical trial of a medical therapy or device.
  • No documented stroke or transient ischemic attack within 6 months of study participation
  • No documented critical carotid artery stenosis (>70%)
  • No retinitis pigmentosa.
  • The patient has authorized his/her consent to participate in this trial pre-operatively OR consent to participation is granted on the patient's behalf by a substitute decision maker pre or post operatively.

POST-OPERATIVELY

  • A pulmonary arterial catheter (swan-ganz catheter) is insitu.
  • The patient has a mPAP measurement of >/= 25mmHg for at least 1 hour.
  • The patient has a mean arterial pressure (MAP) of >/= 65mmHg.
  • The patient has a heart rate of greater than 40 and less than 130 beats/minute.
  • The patient is intubated and mechanically ventilated as per standard ventilation protocol at St. Michael's Hospital.
  • The patient has not received intravenous nitroglycerin or nitroprusside within 1 hour before treatment with study medication.

Exclusion Criteria:

POST-OPERATIVELY

  • The patient requires nitroglycerin based medications continuously (topical/oral/intravenous)
  • The patient has an arterial pH of < 7.30 or ≥ 7.47
  • The patient has clinical and or documented laboratory evidence from routine blood work of renal dysfunction or failure. (Doubling of pre-operative creatinine or requiring dialysis is indicative of renal dysfunction.)
  • The patient has clinical and or documented laboratory evidence from routine blood work of significant hepatic disease or failure. (ALT or AST 5 times ULN or obvious jaundice will be indicative of liver dysfunction)
  • The patient's current medical condition in the opinion of the investigator and/or the patient's attending ICU physician makes him/her inappropriate for participation in this study.
  • The patient is currently a participant in a clinical trial of an investigational therapy including a drug or medical device.
  • The patient has clinical indications of sepsis defined as 2 of the following five criteria: i) leukocytosis (or) leukopenia: wbc >12 x 109/L (or) <4x109/L (>10% bands also, ii) fever (or) hypothermia (temp >38.5C or <36C), iii) tachycardia, hr > 90 beats/minute, iv) tachypnea, respiratory rate (RR) >18 breaths/minute, v) hypotension, SBP <90 mmHg
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00334490

Contacts
Contact: David Mazer, MD     416-864-5825     mazerd@smh.toronto.on.ca    
Contact: Doug G. Michaud, H.B.Sc.     416-864-6060 ext 2920     michaudd@smh.toronto.on.ca    

Locations
Canada, Ontario
St. Michael's Hospital     Recruiting
      Toronto, Ontario, Canada, M5B 1W8
      Principal Investigator: David Mazer, MD            

Sponsors and Collaborators
St. Michael's Hospital, Toronto
University of Toronto

Investigators
Principal Investigator:     David Mazer, MD     St. Michael's Hospital, Toronto    
  More Information


Study ID Numbers:   091532, REB 04-093
First Received:   June 6, 2006
Last Updated:   September 2, 2008
ClinicalTrials.gov Identifier:   NCT00334490
Health Authority:   Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
Pulmonary Hypertension  
Sildenafil  
Viagra  
Cardiac Surgery  
Cardiopulmonary Bypass  

Study placed in the following topic categories:
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Vascular Diseases
Sildenafil
Hypertension

Additional relevant MeSH terms:
Vasodilator Agents
Phosphodiesterase Inhibitors
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Enzyme Inhibitors
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 14, 2008




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