A randomized, placebo controlled, single center clinical trial for evaluation of efficacy and safety of Sildenafil administration in the cardiac ICU following Mitral Valve (MV) Surgery in patients with pre-operative Significant Pulmonary Hypertension.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Sildenafil administration in the cardiac ICU following Mitral Valve Surgery concomitant with best practice usual care
Placebo comparator concomitant with best practice usual care
Cardiac Surgical Department, Leviev Heart Center
Ramat Gan, Tel Hashomer, Israel
To evaluate if sildenafil results in greater reduction in average mean pulmonary artery pressure (mPAP) compared to placebo. (Percent change in mPAP pressure at 48 hours as compared to the immediate post operative averages.)
Percent change in mPAP pressure at 48 hours as compared to the immediate post operative averages. Pulmonary pressures will be obtained through invasive hemodynamic measurements
Time frame: 48 hours
Time on mechanical ventilation
Time frame: 96 hours
Total surgical intensive care time
Duration of Surgical ICU stay
Time frame: participants will be followed for the duration of ICU stay, an expected average of 4 days
Change in functional capacity post operation (Change in NYHA functional class (optional 6MWT pre-discharge)
Change in NYHA functional class (optional 6 minute walk test \[6MWT\] pre-discharge)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
Study treatment related serious adverse events
Absence of serious adverse events related to study drug (shock, organ hypoperfusion, significant arrythmia and any other major event as defined by GCP guidelines) during hospital stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 days
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