PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: June 2018

Interventions

  • Drug: Sildenafil
    • Sildenafil administration in the cardiac ICU following Mitral Valve Surgery concomitant with best practice usual care
  • Drug: Placebo
    • Placebo comparator concomitant with best practice usual care

Arms, Groups and Cohorts

  • Experimental: Sildenafil
    • 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 Comparator: Placebo
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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.)
    • Time Frame: 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 Measures

  • Time on mechanical ventilation
    • Time Frame: 96 hours
  • Total surgical intensive care time
    • Time Frame: 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)
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dr. Robert Klempfner Heart Rehabilitation Institute
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dr. Robert Klempfner Heart Rehabilitation Institute, Dr. Ferstenfeld Ido – Sheba Medical Center

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