ISRCTN12903789进行中（未招募）2 期
Targeted heart rate control using the funny current inhibitor ivabradine to reduce morbidity in patients undergoing non-cardiac surgery: a phase IIa, triple blind, placebo controlled randomised trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 350
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria of as 07/03/2023:
- •1. Patients aged 55 years and over
- •2. Undergoing elective or urgent non-cardiac surgery requiring general and/or regional anaesthesia with sedation, expected to take longer than 120 minutes from the induction of anaesthesia
- •3. At least one medical risk factor for perioperative myocardial injury
- •4. History of hypertension (requiring anti-hypertensive drug) or hypertension recorded in the pre-assessment clinic [BP>140mmHg systolic; >90 mmHg diastolic]
- •Previous participant inclusion criteria:
- •1. Patients aged 55 years and over
- •2. Undergoing elective or urgent non-cardiac surgery requiring general and/or regional anaesthesia with sedation, expected to take longer than 120 minutes from the induction of anaesthesia
- •3. At least one medical risk factor for perioperative myocardial injury
排除标准
- •Current participant exclusion criteria of as 07/03/2023:
- •1. Inability or refusal to provide informed consent
- •2. Patients lacking capacity
- •3. Prior use of ivabradine within the previous 30 days
- •4. Current participation in a clinical trial of a treatment with a similar biological mechanism
- •5. Previous enrolment into FUNNY trial
- •6. Contraindication to ivabradine
- •7. History of hypersensitivity or allergy to ivabradine or any of its excipients
- •8. Women of childbearing potential (this includes pregnancy and lactation). A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant unless permanently sterile
- •9. Patients with atrial fibrillation (persistent/chronic or paroxysmal)
- •Previous participant exclusion criteria:
- •1. Inability or refusal to provide informed consent
- •2. Patients lacking capacity
- •3. Prior use of ivabradine within the previous 30 days
- •4. Current participation in a clinical trial of a treatment with a similar biological mechanism
- •5. Previous enrolment into FUNNY trial
- •6. Contraindication to ivabradine
- •7. History of hypersensitivity or allergy to ivabradine or any of its excipients
- •8. Women of childbearing potential (this includes pregnancy and lactation). A woman of childbearing potential is defined as a premenopausal female capable of becoming pregnant unless permanently sterile
研究者
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