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PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT02378649
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Robert Klempfner Heart Rehabilitation Institute, Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Mitral Valve Surgery Drug: Sildenafil Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Drug: Sildenafil
Sildenafil administration in the cardiac ICU following Mitral Valve Surgery concomitant with best practice usual care
Other Name: Revatio \ Viagra

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.

Drug: Placebo
Placebo comparator concomitant with best practice usual care




Primary Outcome Measures :
  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.) [ 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 Outcome Measures :
  1. Time on mechanical ventilation [ Time Frame: 96 hours ]
  2. 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

  3. 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)

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02378649


Locations
Israel
Cardiac Surgical Department, Leviev Heart Center
Ramat Gan, Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Dr. Robert Klempfner Heart Rehabilitation Institute

Responsible Party: Dr. Robert Klempfner Heart Rehabilitation Institute, Dr. Ferstenfeld Ido, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02378649     History of Changes
Other Study ID Numbers: 1839-14-SMC
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018

Keywords provided by Dr. Robert Klempfner Heart Rehabilitation Institute, Sheba Medical Center:
Pulmonary Hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Lung Diseases
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents