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PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension, Mitral Valve Surgery

Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Sildenafil
Placebo
Sponsored by
Dr. Robert Klempfner Heart Rehabilitation Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Pulmonary Hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiac Surgical Department, Leviev Heart Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sildenafil

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time on mechanical ventilation
Total surgical intensive care time
Duration of Surgical ICU stay
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)
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

Full Information

First Posted
February 5, 2015
Last Updated
June 24, 2018
Sponsor
Dr. Robert Klempfner Heart Rehabilitation Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02378649
Brief Title
PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Robert Klempfner Heart Rehabilitation Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension, Mitral Valve Surgery
Keywords
Pulmonary Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sildenafil
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Other Intervention Name(s)
Revatio \ Viagra
Intervention Description
Sildenafil administration in the cardiac ICU following Mitral Valve Surgery concomitant with best practice usual care
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator concomitant with best practice usual care
Primary Outcome Measure Information:
Title
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.)
Description
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
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Time on mechanical ventilation
Time Frame
96 hours
Title
Total surgical intensive care time
Description
Duration of Surgical ICU stay
Time Frame
participants will be followed for the duration of ICU stay, an expected average of 4 days
Title
Change in functional capacity post operation (Change in NYHA functional class (optional 6MWT pre-discharge)
Description
Change in NYHA functional class (optional 6 minute walk test [6MWT] pre-discharge)
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 days
Title
Study treatment related serious adverse events
Description
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
Time Frame
participants will be followed for the duration of hospital stay, an expected average of 6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Cardiac Surgical Department, Leviev Heart Center
City
Ramat Gan
State/Province
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel

12. IPD Sharing Statement

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PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension

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