Levothyroxine Supplementation for Heart Transplant Recipients: A Randomized Control Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Number of participants who receive Levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use.
研究概览
简要总结
This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.
详细描述
Studies have shown that thyroid hormone results in a higher number of organs available for transplant. Increasingly, thyroid hormone supplementation is used amongst transplant donors. However, it is not the current standard of practice to supplement recipients without a prior medical history of hypothyroidism with levothyroxine. Two large retrospective studies have demonstrated improved 30-days survival and lower risk of all-cause mortality for heart transplant recipients who receive levothyroxine in the post-operative context. No randomized trials have tested this hypothesis and so the investigators aim to trial the use of levothyroxine for heart transplant recipients at University of California San Francisco using a double-blinded and placebo controlled randomized control trial study design. This will be a prospective, randomized study performed at a single tertiary referral academic medical center (University of California San Francisco, CA), evaluating the survival benefits of levothyroxine compared with no levothyroxine for patients who have undergone heart transplant. It will be double-blinded and placebo-control; participants will be randomized to receive levothyroxine or receive no levothyroxine.
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
- Double (Participant, 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
- •Participants must be listed for heart transplantation
- •Age ≥18 years
- •Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •Patients with pre-existing thyroid related condition including hypothyroidism, hyperthyroidism and malignancy
- •Patients with a known allergy or intolerance to levothyroxine
- •Patients participating in another study evaluating an investigational drug within the past 30 days.
研究组 & 干预措施
No Levothyroxine
Patients will be double-blinded and randomized to receive no levothyroxine. The placebo will be normal saline.
干预措施: Normal saline (Drug)
Levothyroxine
Patients will be double-blinded and randomized to receive levothyroxine.
干预措施: Levothyroxine (Drug)
结局指标
主要结局
Number of participants who receive Levothyroxine's vasopressor use compared to number of participants who receive normal saline's vasopressor use.
时间窗: 35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis
Measured using the vasoactive-inotropic score (VIS) scale. VIS calculation: dopamine dose (μg/kg/min) + dobutamine dose (μg/kg/min) + 100 × epinephrine dose (μg/kg/min) + 10 × milrinone dose (μg/kg/min) + 10 000 × vasopressin dose (unit/kg/min) + 100 × norepinephrine dose (μg/kg/min)
次要结局
- Does the total vasoactive-inotropic score (VIS) decrease for patients who receive levothyroxine?(35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis)
- Do the participants have improved cardiac output?(35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis)
- Do the participants receiving levothyroxine experience lower frequencies of primary graft dysfunction?(35 months total completion, 18 months accrual, 12 months follow up and 5 months data analysis)