Clinical trial NCT02378649: PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension
Official title: A Randomized, Placebo Controlled, Single Center Clinical Trial for Evaluation of Efficacy and Safety of Sildenafil Administration in the Cardiac ICU Following Mitral Valve Surgery in Patients With Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Hypertension
Mitral Valve Surgery
Keywords: Pulmonary Hypertension
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2015-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.)
timeFrame: 48 hours
Secondary outcomes:
measure: Time on mechanical ventilation
timeFrame: 96 hours
measure: Total surgical intensive care time
timeFrame: participants will be followed for the duration of ICU stay, an expected average of 4 days
measure: Change in functional capacity post operation (Change in NYHA functional class (optional 6MWT pre-discharge)
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
measure: Study treatment related serious adverse events
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 6 days
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Cardiac Surgical Department, Leviev Heart Center
state: Tel Hashomer
Study officials:
References: