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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 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.)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Sildenafil (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
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.)
时间窗: 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
次要结局
- Time on mechanical ventilation(96 hours)
- Study treatment related serious adverse events(participants will be followed for the duration of hospital stay, an expected average of 6 days)
- 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)
研究者
Dr. Robert Klempfner Heart Rehabilitation Institute
Dr. Ferstenfeld Ido
Sheba Medical Center