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临床试验/NCT05931276
NCT05931276招募中3 期

CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes (BRAVO)

VA Office of Research and Development10 个研究点 分布在 1 个国家目标入组 2,540 人开始时间: 2024年5月22日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
招募中
入组人数
2,540
试验地点
10
主要终点
Time to major cardiovascular event

研究概览

简要总结

The investigators aim to determine, using a point-of-care randomized controlled trial design, if hemodialysis patients, who are randomized to metoprolol succinate (a dialyzable, beta-1 selective beta blocker), have an improved cardiovascular outcome compared to those randomized to carvedilol (a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties). The investigators will also examine intervention practices to identify components that best support engagement and sustainability.

详细描述

Approximately 35,000 Veterans have end stage kidney disease (ESKD) with an incidence of 13,000 annually. These numbers are increasing because of the epidemic of diabetes, the most common cause of ESKD, among the Veteran population. Patients with ESKD on hemodialysis have substantial cardiovascular morbidity. Veterans annual mortality is in excess of 15% and more than half the deaths are due to cardiovascular disease. Beta blockers have been shown to prevent cardiovascular events in randomized clinical trials in patients without chronic kidney disease, particularly those with heart failure and after myocardial infarction. Beta blockers are a mainstay of therapy in dialysis patients, with two-thirds of Veterans on dialysis receiving a beta blocker. There are no head-to-head randomized studies comparing the two most commonly used beta blockers in ESKD patients in the United States, metoprolol and carvedilol, but observational studies suggest superior outcomes for patients treated with metoprolol. The identification of the superior beta blocker may significantly improve the morbidity and mortality of the VA dialysis population.

The investigators aim to compare two beta blockers with similar indications, usage and availability within the VA but with major differences in patients dialysis clearance and adrenergic effects. The investigators aim to determine if patients undergoing dialysis have improved survival when using metoprolol succinate, a beta blocker that is removed by dialysis and is beta-1 selective, compared to carvedilol, a beta blocker that is not removed by dialysis and is not beta-selective and is also an alpha-blocker.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • On hemodialysis
  • Received one of the following beta blockers through the VA pharmacy: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, bisoprolol

排除标准

  • Impaired decision-making capacity
  • Patients not receiving carvedilol who have a history of asthma
  • known hypersensitivity to any component of either drug
  • Provider unwilling to sign a new medication order for a randomized patient
  • No surrogate consent will be allowed

研究组 & 干预措施

Carvedilol

Active Comparator

Depending on baseline type and dose of beta blocker:

  • 3.125 mg twice daily
  • 6.25 mg twice daily
  • 12.5 mg twice daily
  • 25 mg twice daily (may titrate to 5 0mg twice daily if > 85 kg)

干预措施: Carvedilol (Drug)

Metoprolol Succinate

Active Comparator

Depending on baseline type and dose of beta blocker:

  • 25 mg once daily (12.5 mg once daily if > NYHA class II)
  • 50 mg (or 25 mg) once daily
  • 100 mg (or 50 mg) once daily
  • 200 mg (or 100 mg titrated to 200 mg) once daily

干预措施: Metoprolol Succinate (Drug)

结局指标

主要结局

Time to major cardiovascular event

时间窗: Randomization to time to event; average follow-up 3 years

The Primary outcome measure will be time to a non-fatal adverse cardiovascular event, defined as a composite outcome comprised of the first occurrence after randomization of any of the following: myocardial infarction, stroke, or hospitalization for heart failure, and all-cause mortality

次要结局

  • Non-fatal stroke(Randomization to time to event; average follow-up 3 years)
  • Hospitalization for heart failure(Randomization to time to event; average follow-up 3 years)
  • Non-fatal myocardial infarction(Randomization to time to event; average follow-up 3 years)
  • All-cause mortality(Randomization to time to event; average follow-up 3 years)

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (10)

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