Regulation of Cardiac Function After TAVR in Patients With Severe Aortic Stenosis Combined With Cardiac Insufficiency: a Prospective, Single-center, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Left ventricular ejection fraction （one month after TAVR）
研究概览
简要总结
Patients with severe aortic stenosis combined with severe heart failure often miss the opportunity for surgery, and the prognosis is poor with drug therapy alone.In recent years, the emergence of transcatheter aortic valve replacement (TAVR) has brought new hope for these patients, and since its birth in 2002, TAVR has been widely used internationally, and its safety and efficacy have been confirmed by several large, prospective, randomized controlled studies.
Levosimendan is a new type of positive inotropic drug. It not only enhances myocardial contractile force through calcium sensitization, but also activates K+ sensitive channel KATP on the membrane of vascular smooth muscle, relaxes the arteries and veins of the whole body, and reduces the front and back load of the heart, pulmonary vascular resistance and systemic vascular resistance. A series of studies suggested that for patients undergoing thoracotomy in various cardiac surgeries, regardless of whether the patients were accompanied by ventricular systolic dysfunction before surgery, the use of levosimendan resulted in significantly higher postoperative cardiac function and decreased mortality than the control group, and patients with preoperative LVEF < 40% benefited more.
At present, there are no studies to clarify the regulatory effect of levosimendan on cardiac function after TAVR in patients with severe aortic stenosis complicated with cardiac insufficiency. This is a randomized controlled study. On the basis of basic drug therapy, the treatment group was given levosimendan to analyze the regulatory effect of levosimendan on cardiac function after TAVR.
详细描述
We plan to recruit 112 patients with severe aortic stenosis and cardiac insufficiency, which，after TAVR, were randomly divided into treatment group (56 cases, intravenous levosimendan) and control group (56 cases).
The treatment group was given levosimendan injection intravenously once: 12.5mg levosimendan injection was diluted to 50ml with 5% glucose injection, the initial pump speed was 2ml/h, and maintained for 24 hours.
In the process of drug q1h monitoring blood pressure. If the systolic blood pressure was lower than 90mmHg, the blood pressure was remeasured 5 minutes later. If the systolic blood pressure was still lower than 90mmHg, 10mg norepinephrine injection +45ml 5% glucose injection was given intravenously by micro pump, the initial 2ml/h. The blood pressure was monitored, and the pump speed was adjusted according to the blood pressure to maintain the systolic blood pressure at 90-110mmHg.
Preoperative and postoperative immediately, after 3 days and postoperative 1 month, electrocardiogram, echocardiography and venous blood. Three tubes of venous blood were collected each time, and each tube was sent to the laboratory department of Qilu Hospital for blood routine, liver and kidney function, blood biochemistry, NT-proBNP and troponin I detection. The remaining samples were destroyed immediately after detection. The results of 6-minute walk test and the incidence of cardiovascular events were recorded at 1 month after operation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged 65-85 years undergoing TAVR;
- •Echocardiography diagnosed severe aortic valve stenosis with LVEF<0.4；
- •Prior to the initiation of the study, the patients or their legal representatives signed the informed consent form.
排除标准
- •Adverse reactions to levosimendan or other excipients;
- •In addition to the aortic valve disease, still with cardiac mechanical obstructive diseases;
- •Patients with severe hepatic and renal impairment (creatinine clearance <30ml/min);
- •Patients with severe hypotension (SBP<90mmHg or DBP<60mmHg) and ventricular tachycardia, ventricular fibrillation, and frequent premature ventricular contractions.
- •Severe complications occurred during TAVR.
- •Are involved in other clinical studies
- •Other clinically significant respiratory, digestive, hematological, infectious, immune, endocrine, neuropsychiatric, tumor diseases, etc.
研究组 & 干预措施
Levosimontane group
name：Levosimendan injection dose：12.5mg；once；24h
干预措施: Levosimontane injection (Drug)
结局指标
主要结局
Left ventricular ejection fraction （one month after TAVR）
时间窗: one month
At 1-month follow-up, left ventricular ejection fraction was measured by echocardiography in patients with severe aortic stenosis complicated with heart failure after TAVR.
次要结局
- Left ventricular size(one month)
- left ventricular wall thickness(one month)
- NT-proBNP(one month)
- Left ventricular global long axis strain(one month)
- aortic valve orifice area(one month)
- The result of 6-minute walking experiment(one month)
- Incidence of cardiovascular events(one month)