Mitral Valve Surgery, Pulmonary Hypertension
Conditions
Keywords
Pulmonary Hypertension
Brief summary
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.
Interventions
DRUGPlacebo
Placebo comparator concomitant with best practice usual care
DRUGSildenafil
Sildenafil administration in the cardiac ICU following Mitral Valve Surgery concomitant with best practice usual care
Sponsors
Dr. Robert Klempfner Heart Rehabilitation Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 22 2. Undergoing mitral valve surgery (either repair or replacement) with or without coronary revascularization, aortic valve replacement (AVR) or repair; or tricuspid valve surgery. 3. Pre-operative pulmonary arterial systolic pressure \>50 mm Hg as determined by resting echocardiography and post-operative sPAP \> 45 mmHg as obtained from invasive hemodynamics measurements. 4. Willing and able to give written informed consent prior to the procedure
Exclusion criteria
1. Hypersensitivity to study drug 2. Women of child-bearing potential 3. Expected need to administer nitrates that are clinically indicated peri-operatively 4. Post-operative hypotension (systolic blood pressure (BP) \<80) or evidence of shock (postoperative evidence of any kinds of shock) 5. Cardiac or systemic amyloidosis 6. Active malignancy other than BCC (basal cell carcinoma) 7. Stable kidney dysfunction with Creatine clearence (CrCl) \<30 mL/min during the screening period or hepatic failure other than mild 8. Significant anemia (hemoglobin \<8 mg/dl) preoperative. 9. Known drug or alcohol dependence or any other factors which will interfere with the study conduct or interpretation of the results or in the opinion of the investigator are not suitable to participate; 10. Any illness other than cardiac which might reduce life expectancy to less than 1 year from screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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.) | 48 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time on mechanical ventilation | 96 hours | — |
| Total surgical intensive care time | participants will be followed for the duration of ICU stay, an expected average of 4 days | Duration of Surgical ICU stay |
| Change in functional capacity post operation (Change in NYHA functional class (optional 6MWT pre-discharge) | participants will be followed for the duration of hospital stay, an expected average of 6 days | Change in NYHA functional class (optional 6 minute walk test \[6MWT\] pre-discharge) |
| Study treatment related serious adverse events | participants will be followed for the duration of hospital stay, an expected average of 6 days | 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 |
Countries
Israel
Outcome results
None listed