PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension

NCT02378649 | Completed Phase 4

• 1 other identifier: 1839-14-SMC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension; Mitral Valve Surgery

Keywords

Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Time on mechanical ventilation

  96 hours

• Total surgical intensive care time

  participants will be followed for the duration of ICU stay, an expected average of 4 days

• 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

• Study treatment related serious adverse events

  participants will be followed for the duration of hospital stay, an expected average of 6 days

Study Arms (2)

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.

Drug: Sildenafil

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.

Drug: Placebo

Interventions

Sildenafil DRUG

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

Also known as: Revatio \ Viagra

Sildenafil

Placebo DRUG

Placebo comparator concomitant with best practice usual care

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Robert Klempfner Heart Rehabilitation Institute: lead

Study Sites (1)

Cardiac Surgical Department, Leviev Heart Center

Ramat Gan, Tel Hashomer, 52621, Israel

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Ferstenfeld Ido

Study Record Dates

• First Submitted: February 5, 2015
• First Posted: March 4, 2015
• Study Start: March 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 26, 2018

Record last verified: 2018-06

Locations

IL (1)