PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02378649
• Other study ID #: 1839-14-SMC
• Status: Completed
• Phase: Phase 4
• Start date: March 2015
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Mitral Valve Surgery
• Pulmonary Hypertension

Intervention

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

Locations

Country	Name	City	State
Israel	Cardiac Surgical Department, Leviev Heart Center	Ramat Gan	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Robert Klempfner Heart Rehabilitation Institute

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	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	48 hours
Secondary	Time on mechanical ventilation		96 hours
Secondary	Total surgical intensive care time	Duration of Surgical ICU stay	participants will be followed for the duration of ICU stay, an expected average of 4 days
Secondary	Change in functional capacity post operation (Change in NYHA functional class (optional 6MWT pre-discharge)	Change in NYHA functional class (optional 6 minute walk test [6MWT] pre-discharge)	participants will be followed for the duration of hospital stay, an expected average of 6 days
Secondary	Study treatment related serious adverse events	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	participants will be followed for the duration of hospital stay, an expected average of 6 days