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CompletedNCT00334490Updated Jul 31, 2015

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

A Phase 2 interventional study of Sildenafil and Sildenafil in Pulmonary Hypertension, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-31.

Sponsored by Unity Health Toronto · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

Sildenafil citarte is a selective pulmonary vasodilator without profound effects on systemic hemodynamics making it an attractive option for treating post operative pulmonary hypertension in the cardiac surgical patients. It is inexpensive and feasible to administer. Intravenous as well as oral doses have been shown to reduce the mean pulmonary arterial pressure (mPAP) and pulmonary vascular resistance (PVR) in animal models as well as in clinical trials with adults with primary pulmonary hypertension and children after cardiac surgery . However, no data exists to support the safety and efficacy of Sildenafil citrate in the adult cardiac surgical population. The purpose of this study is to further investigate the potential role of Sildenafil citrate to treat post operative pulmonary hypertension in the cardiac population.

02

Conditions studied

  • Pulmonary Hypertension

Keywords

  • Pulmonary Hypertension
  • Sildenafil
  • Viagra
  • Cardiac Surgery
  • Cardiopulmonary Bypass
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 40 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    1

    Oral Sildenafil 12.5 mg

    Drug: Sildenafil

  • Placebo comparator
    2

    Placebo in 5 mls distilled water

    Drug: Placebo

Interventions

  • DrugSildenafil

    12.5 mg Sildenafil once with optional second dose

    Also known as: Viagra

  • DrugSildenafil

    12.5 mg orally once with optional second dose

    Also known as: Viagra

  • DrugPlacebo

    Oral Placebo in 5 mls distilled water

    Also known as: Viagra

06

What researchers measure

Primary outcomes

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

    Time frame: Begining 2 hours postoperatively through 75 minutes post dosing

Secondary outcomes

  1. 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.

    Time frame: From post operative dosing through to hospital discharge

  2. To determine the safety of oral sildenafil to treat increased mPAP after cardiac surgery.

    Time frame: Begining 2 hours postoperatively through discharge from the hospital

07

Study locations

1 site
  • St. Michael's Hospital
    Toronto, Ontario M5B 1W8, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00334490
Lead sponsor
Unity Health Toronto
Collaborators
University of Toronto
Responsible party
Sponsor
First posted
Jun 7, 2006
Start date
Mar 2005
Primary completion
Apr 2009
Completion
May 2009
Last update
Jul 31, 2015

Study contacts

David Mazer, MD
principal investigator · Unity Health Toronto

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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