PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension

Phase 4

Completed

• Conditions: Pulmonary Hypertension; Mitral Valve Surgery
• Interventions: Drug: Placebo; Drug: Sildenafil

• Registration Number: NCT02378649
• Lead Sponsor: Dr. Robert Klempfner Heart Rehabilitation Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-05
• Study First Submitted QC: 2015-02-26
• Study Start: 2015-03
• Study First Posted: 2015-03-04
• Status Verified: 2018-06
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2018-06-24
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	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.
Sildenafil	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Time on mechanical ventilation	96 hours
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
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)

Trial Locations

Locations (1)

Cardiac Surgical Department, Leviev Heart Center; 🇮🇱 Ramat Gan, Tel Hashomer, Israel