CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Metoprolol Succinate, Carvedilol.
- Кому может быть актуально
- Состояния в реестре: End-Stage Kidney Disease, End-Stage Renal Disease. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
CSP #2026 - Beta Blocker Dialyzability on Cardiovascular Outcomes (BRAVO)
Обзор
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.
Подробное описание
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.
Вмешательства
- Препарат Metoprolol Succinate
a dialyzable, beta-1 selective beta blocker - Препарат Carvedilol
a non-dialyzable, non-selective beta blocker with alpha-1 antagonist properties
Первичные конечные точки
- Time to major cardiovascular event [Срок оценки: Randomization to time to event; average follow-up 3 years]
Вторичные конечные точки (4)
- Non-fatal myocardial infarction [Срок оценки: Randomization to time to event; average follow-up 3 years]
- Non-fatal stroke [Срок оценки: Randomization to time to event; average follow-up 3 years]
- Hospitalization for heart failure [Срок оценки: Randomization to time to event; average follow-up 3 years]
- All-cause mortality [Срок оценки: Randomization to time to event; average follow-up 3 years]
Критерии участия
Критерии включения
- On hemodialysis
- Received one of the following beta blockers through the VA pharmacy: metoprolol (succinate or tartrate), atenolol, labetalol, carvedilol, bisoprolol
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 8 центров
- VA Long Beach Healthcare System, Long Beach, CA — Long Beach
- North Florida/South Georgia Veterans Health System, Gainesville, FL — Gainesville
- Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur
- Iowa City VA Health Care System, Iowa City, IA — Iowa City
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA — Boston
- Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis
- Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE — Omaha
- New Mexico VA Health Care System, Albuquerque, NM — Albuquerque
Публикации
- Leatherman SM, Ishani A. Point-of-Care Clinical Trials in Nephrology. J Am Soc Nephrol. 2024 Jun 1;35(6):812-814. doi: 10.1681/ASN.0000000000000340. Epub 2024 Feb 29. No abstract available. PMID 38419159
Идентификаторы
NCT: NCT05931276 · 2026