PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pulmonary Hypertension Mitral Valve Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Sildenafil

Intervention Type DRUG

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

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo comparator concomitant with best practice usual care

Interventions

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Sildenafil

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

Intervention Type DRUG

Placebo

Placebo comparator concomitant with best practice usual care

Intervention Type DRUG

Other Intervention Names

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Revatio \ Viagra

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No