Меню
Набор по приглашению NCT07298993

Deprescribing Beta-Blockers in Elders With Heart Failure With Preserved Ejection Fraction (DEPRESCRIBE-HFpEF)

Фаза IV С лечением Heart Failure HFpEF HFpEF - Heart Failure With Preserved Ejection Fraction

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: Placebo (matching), Beta-blockers.
Кому может быть актуально
Состояния в реестре: Heart Failure, HFpEF, HFpEF - Heart Failure With Preserved Ejection Fraction. Базовые параметры: от 60 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Determining Evidence in a Placebo-Controlled, Randomized Experiment Studying Continuation vs. Removal of Inessential Beta-Blockers in Elders With Heart Failure With Preserved Ejection Fraction (DEPRESCRIBE-HFpEF)

Обзор

The goal of this study is to learn whether stopping beta-blockers can help older adults with heart failure with preserved ejection fraction (HFpEF) feel better and function better. This study will test whether "deprescribing" or stopping these medications in a careful, guided way can improve symptoms and quality of life. Participants will be randomly assigned to one of two groups: Deprescribing group: Beta-blockers are gradually reduced using capsules that contain decreasing doses. Usual care group: Beta-blockers are continued at the usual dose in look-alike capsules. All participants will: * Take study medicine for about 4 months * Have their blood pressure and heart rate monitored * Complete regular phone calls and questionnaires about how they are feeling This study does not involve any experimental medication. Participants active involvement in the study will last approximately 4 months. During these 4 months they will have 8 scheduled telephone visits.

Вмешательства

  • Препарат Placebo (matching)
    Beta-blocker dosage will be reduced over the course of 4 weeks until the participant is completely off of beta-blocker and transitioned to matching placebo capsules.
  • Препарат Beta-blockers
    Participants will continue their pre-enrollment beta-blocker at the same dose. The beta-blocker agent may include atenolol, bisoprolol, carvedilol, metoprolol succinate, or metoprolol tartrate. Medication will be provided in matching capsules to maintain blinding.

Первичные конечные точки

  • The Hierarchical Composite Endpoint [Срок оценки: From baseline (day 0) to end of the follow-up phase (day 120)]
Вторичные конечные точки (2)
  • The change from baseline in patient-reported physical health, as measured by the KCCQ-12 [Срок оценки: Baseline, Day 120]
  • The change in patient-reported mental health, as measured by the PROMIS Depression scale [Срок оценки: Baseline, Day 120]

Критерии участия

Критерии включения

  • Ambulatory adults age ≥60 years with HFpEF (EF ≥50% based on most recent transthoracic echocardiogram)
  • Hospitalized with HF in the past 24 months (defined by diagnostic codes in any position)
  • Taking any of the following ß-blockers: atenolol, bisoprolol, carvedilol, metoprolol succinate, or metoprolol tartrate (i.e., pharmacy prescription data)
  • Kaiser Permanence Northern California Membership

Критерии исключения

  • Alternative etiologies of HFpEF syndrome
  • Compelling guideline indication for ß-blocker:
  • Prior EF <50% (i.e., based on the structured data field on transthoracic echocardiogram)
  • Current anginal symptoms (i.e., based on the Rose Angina single-question screener for angina)
  • MI (i.e., diagnostic codes) and/or coronary revascularization (i.e., procedure codes) within 3 years
  • Hospitalization for a primary discharge diagnosis of atrial fibrillation or atrial flutter in the prior 12 months
  • Other documented reason in the opinion of the treating provider and/or enrolling clinician-investigator
  • Evidence of recent decompensated HF
  • Hospitalization for a primary discharge diagnosis of HF within the past 30 days
  • Change in loop diuretic pharmacy prescription in the past 30 days (i.e. pharmacy prescription data) (Note: This definition is based on documented prescription changes and does not include short-term dose adjustments that were verbally communicated to the patient by their provider.)
  • Estimated life expectancy <6 months (i.e., diagnostic codes)
  • Diagnosed dementia (i.e.., diagnostic codes)
  • Unable to provide informed consent
  • Loss of Kaiser Permanence Northern California Membership

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
Четверное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Kaiser Permanente Northern California (KPNC) — Pleasanton

Идентификаторы

NCT: NCT07298993 · 24-08027899 · R01AG091005

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗