Trial | NCT02378649  Report issue

Title

PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    sildenafil ...

  • Study Participants

    60
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 Started
Mar 31
2015
Primary Completion
Jun 30
2018
Study Completion
Jun 30
2018
Last Update
Jun 26
2018

Drug Sildenafil

Sildenafil administration in the cardiac ICU following Mitral Valve Surgery concomitant with best practice usual care

  • Other names: Revatio \ Viagra

Drug Placebo

Placebo comparator concomitant with best practice usual care

Sildenafil Experimental

PDEI or placebo will be administered in the surgical ICU 4-6 hours after arriving from the Operative Room. The initial Dose will be 20mg X 3 NG and can be increase to 40mg X 3, it will be administered PO if the patient extubated. PDEI or placebo will continue up to 8 days or discharge.

Placebo Placebo Comparator

PDEI or placebo will be administered in the surgical ICU 4-6 hours after arriving from the Operative Room. The initial Dose will be 20mg X 3 NG and can be increase to 40mg X 3, it will be administered PO if the patient extubated. PDEI or placebo will continue up to 8 days or discharge.

Criteria 

Inclusion Criteria:

Age ≥ 22
Undergoing mitral valve surgery (either repair or replacement) with or without coronary revascularization, aortic valve replacement (AVR) or repair; or tricuspid valve surgery.
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.
Willing and able to give written informed consent prior to the procedure

Exclusion Criteria:

Hypersensitivity to study drug
Women of child-bearing potential
Expected need to administer nitrates that are clinically indicated peri-operatively
Post-operative hypotension (systolic blood pressure (BP) <80) or evidence of shock (postoperative evidence of any kinds of shock)
Cardiac or systemic amyloidosis
Active malignancy other than BCC (basal cell carcinoma)
Stable kidney dysfunction with Creatine clearence (CrCl) <30 mL/min during the screening period or hepatic failure other than mild
Significant anemia (hemoglobin <8 mg/dl) preoperative.
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;
Any illness other than cardiac which might reduce life expectancy to less than 1 year from screening
No Results Posted