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

NCT00334490 | Completed Phase 2 DMC

• 2 other identifiers: 091532REB 04-093
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Hypertension; Sildenafil; Viagra; Cardiac Surgery; Cardiopulmonary Bypass

Outcome Measures

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.

  Begining 2 hours postoperatively through 75 minutes post dosing

Secondary Outcomes (2)

• 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.

  From post operative dosing through to hospital discharge

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

  Begining 2 hours postoperatively through discharge from the hospital

Study Arms (2)

1

ACTIVE COMPARATOR

Oral Sildenafil 12.5 mg

Drug: Sildenafil

2

PLACEBO COMPARATOR

Placebo in 5 mls distilled water

Drug: Placebo

Interventions

Sildenafil DRUG

12.5 mg Sildenafil once with optional second dose

Also known as: Viagra

1

Placebo DRUG

Oral Placebo in 5 mls distilled water

Also known as: Viagra

2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• University of Toronto: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

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

• David Mazer, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2006
• First Posted: June 7, 2006
• Study Start: March 1, 2005
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 31, 2015

Record last verified: 2015-07

Locations

CA (1)