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Идёт набор NCT07154758

Registry BAsed Optimization Of Therapy in Heart Failure

Без фазы С лечением Heart Failure

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: Screening for need of HFrEF GDMT implementation through SwedeHF.
Кому может быть актуально
Состояния в реестре: Heart Failure. Базовые параметры: Без ограничений · 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
Швеция
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

Optimizing HF Treatment by Registry Screening for Need of Implementation and Referral to the Optimization Outpatient Clinic

Обзор

Rationale. Although several pharmacological treatments, namely renin-angiotensin-system inhibitors, sacubitril/valsartan, beta-blockers, mineralocorticoid receptor antagonists and sodium-glucose cotransporter-2 inhibitors, improve mortality/morbidity in heart failure with reduced ejection fraction (HFrEF), their use in clinical practice is still limited. Aim. The aim of this project is to use the Swedish HF registry to identify HFrEF patients in need of 1) treatment implementation (initiation of treatments/uptitration), 2) screening and treatment of ID, and 3) with an indication for HF devices (CRT or ICD) but not implanted device, 4) referral for physiotherapy. Outcomes. Primary outcome: number of participants experiencing at least one of the following: 1. Drug initiation or uptitration (SGLT2i, MRA, BB, RASi, ARNi, iv iron) 2. ID screening 3. Referral for device therapy (CRT/ICD) Secondary outcome: 1. Number of participants experiencing at least one drug initiation in the interventional vs. control arm. 2. Number of participants experiencing at least one drug dose up-titration in the interventional vs. control arm. 3. Number of participants experiencing referral for CRT or ICD in the interventional vs. control arm. 4. Number of participants screened for iron deficiency in the interventional vs. control arm. Tertiary outcome: 1\. Number of participants referred for physiotherapy in the interventional vs. control arm. Study design. 500 patients will be screened through the Swedish Heart Failure Registry and, whether not on optimal medical treatment, implementation will be started. Outcome will be compared with a control population of 500 patients not enrolled in SwedeHF.

Вмешательства

  • Другое Screening for need of HFrEF GDMT implementation through SwedeHF
    Screening for need of HFrEF GDMT implementation through SwedeHF

Первичные конечные точки

  • Number of participants experiencing at least one event of treatment optimization [Срок оценки: End of implementation for the screening arm; 1-year from index date for the control arm]
Вторичные конечные точки (4)
  • Number of participants experiencing at least one drug initiation in the interventional vs. control arm. [Срок оценки: End of implementation for the screening arm; 1-year from index date for the control arm]
  • Number of participants experiencing at least one drug dose up-titration in the interventional vs. control arm. [Срок оценки: End of implementation for the screening arm; 1-year from index date for the control arm]
  • Number of participants experiencing referral for CRT or ICD in the interventional vs. control arm. [Срок оценки: End of implementation for the screening arm; 1-year from index date for the control arm]
  • Number of participants screened for iron deficiency in the interventional vs. control arm. [Срок оценки: End of implementation for the screening arm; 1-year from index date for the control arm]

Критерии участия

Критерии включения

  • Registration in SwedeHF with an index date after January 1st 2023 for the screening arm. For controls, hospital access after January 1st 2023.
  • HF duration >6 months to ensure that patients had time to go through the treatment optimization process as recommended by the guidelines.
  • HF with reduced EF (HFrEF) defined as categorical or continuous EF ≤40%
  • Capable of giving signed informed consent (for the screening arm)

Критерии исключения

  • Under optimization of HF therapy
  • In judgment of the investigator unlikely to understand or comply with study procedures

Control population is sex and age matched with the SwedeHF screening arm (1:1)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Скрининг

Центры проведения

Швеция · 6 центров
  • Sahlgrenska Universitetssjukhuset — Gothenburg
  • Hemse vårdcentral — Hemse
  • Länssjukhuset Ryhov — Jönköping
  • Karolinska University Hospital — Stockholm
  • St Görans hospital — Stockholm
  • Södersjukhuset — Stockholm

Идентификаторы

NCT: NCT07154758 · 2023-04364-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗