Pulmonary HypertensionPhase 2NCT00334490

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

A Phase 2 study testing Sildenafil in people with Pulmonary Hypertension, run by Unity Health Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Pulmonary Hypertension
What is being tested?: Sildenafil
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteCanada
Study dates: Mar 2005to May 2009
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Canada1 site

St. Michael's Hospital
Toronto, Ontario, M5B 1W8

Other trials in Canada

About this 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

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.

Conditions: Pulmonary Hypertension
Being tested: Sildenafil, Placebo
Keywords: Pulmonary Hypertension, Sildenafil, Viagra, Cardiac Surgery, Cardiopulmonary Bypass
Medical subject headings: Hypertension, Pulmonary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SildenafilDrug
Also called Viagra
12.5 mg Sildenafil once with optional second dose
SildenafilDrug
Also called Viagra
12.5 mg orally once with optional second dose
PlaceboDrug
Also called Viagra
Oral Placebo in 5 mls distilled water

Study groups in NCT00334490
Study group	Role	What they receive
1	Active comparator	Oral Sildenafil 12.5 mg Receives: Drug: Sildenafil
2	Placebo comparator	Placebo in 5 mls distilled water Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

To determine the efficacy of 12.5mg oral sildenafil to decrease the mPAP in patients presenting with a mPAP >/= 25mmHg after cardiopulmonary bypass.
Measured: 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.
Measured: From post operative dosing through to hospital discharge
To determine the safety of oral sildenafil to treat increased mPAP after cardiac surgery.
Measured: Begining 2 hours postoperatively through discharge from the hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2005May 2009

First posted7 Jun 2006 (estimated)
Study startMar 2005
Primary completionApr 2009
Study completionMay 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00334490
Sponsor's protocol ID: 091532
Other IDs: REB 04-093
Status last verified: Jul 2015
First submitted: 6 Jun 2006
Last updated: 31 Jul 2015
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00334490
Acronym / sponsor ID: 091532
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension, Sildenafil, Viagra, Cardiac Surgery, Cardiopulmonary Bypass
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Unity Health TorontoUniversity, hospital or other
Collaborators: University of Toronto
Study start: Mar 2005
Primary completion: Apr 2009 (actual)
Study completion: May 2009 (actual)
First posted: 7 Jun 2006 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: SildenafilOral Sildenafil 12.5 mg
2	Placebo comparator	Drug: PlaceboPlacebo in 5 mls distilled water

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

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)

Key exclusion criteria (8 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SildenafilAlso: Viagra12.5 mg Sildenafil once with optional second dose	Drug	1
SildenafilAlso: Viagra12.5 mg orally once with optional second dose	Drug	1
PlaceboAlso: ViagraOral Placebo in 5 mls distilled water	Drug	2

Primary outcome

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

2 secondary outcomes

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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.

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Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingPhase 3
Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD)
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Study of REGN13335 in Adult Participants With Pulmonary Arterial Hypertension (PAH)
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Active, not recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Mazer, MD principal investigator

Unity Health Toronto

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sildenafil in people with Pulmonary Hypertension, run by Unity Health Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00334490.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.