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Completed

NCT Number: NCT02378649

PDEI Following Mitral Valve Surgery in Patients With Pulmonary Hypertension

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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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Mitral Valve Surgery Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiac Surgical Department, Leviev Heart Center

Ramat Gan, Tel Hashomer, 52621, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

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

Other names: Revatio \ Viagra

Placebo

Drug

Placebo comparator concomitant with best practice usual care

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.)

    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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dr. Robert Klempfner Heart Rehabilitation Institute

Other Gov

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 4, 2015
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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