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
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.
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.
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.
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POST-OPERATIVELY
Exclusion Criteria:
POST-OPERATIVELY
Oral Sildenafil 12.5 mg
Drug: Sildenafil
Placebo in 5 mls distilled water
Drug: Placebo
12.5 mg Sildenafil once with optional second dose
Also known as: Viagra
12.5 mg orally once with optional second dose
Also known as: Viagra
Oral Placebo in 5 mls distilled water
Also known as: Viagra
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
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
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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Unity Health Toronto