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Набор скоро начнётся NCT07647848

Therapy Adjustment and IndividuaLized Response With Biomarker Observation in ReaL-world Heart Failure

— Наблюдательное Chronic Heart Failure Acute Decompensated 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Chronic Heart Failure, Acute Decompensated Heart Failure. 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
Список центров уточняется — проверьте первичный протокол.
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

Therapy Adjustment and IndividuaLized Response With Biomarker Observation in ReaL-world Heart Failure (TAILOR-HF)

Обзор

The goal of TAILOR-HF is to integrate clinical data, laboratory parameters, treatment patterns, and circulating biomarkers to identify factors that predict individual response to pharmacological treatment in patients with heart failure. TAILOR-HF is an observational study with protocol-mandated assessments scheduled at baseline and at 1, 3, and 6 months after enrolment. Additional follow-up data will be collected through telephone visits every 6 months until the last participant has completed the protocol-mandated 6-month visit.

Первичные конечные точки

  • time to death or a worsening heart failure event [Срок оценки: 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.]
Вторичные конечные точки (5)
  • Time to cardiovascular (CV) mortality [Срок оценки: 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.]
  • Time to first (re)-hospitalization due to heart failure [Срок оценки: 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.]
  • Time to all-cause hospitalization [Срок оценки: 6 months, further long time follow up will be conducted by 6 monthly telephone calls until last patient included in the study has completed primary 6 months follow-up.]
  • Change in clinical congestion score(10) between baseline and 6 months [Срок оценки: 6 months]
  • Change in QoL according to the KCCQ-CSS between baseline and 6 months [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Provide written and dated informed consent for participation prior to trial admission,
  • Age ≥18 years, female or male
  • A clinical diagnosis of new onset or worsening of heart failure with a left-ventricular ejection fraction of <50%
  • On treatment with oral or i.v. furosemide ≥40 mg/day or equivalent (bumetanide 1mg, torasemide 10mg)
  • Receiving <50% of the target doses of at least one of the guidelines recommended pharmacological therapies (clear intolerance not considered)
  • Anticipated or planned uptitration

Критерии исключения

  • Scheduled or on renal replacement therapy,
  • Clearly documented intolerance to two or more of the following groups of drugs: BB, ARNI, SGLT2i or MRAs.
  • Diagnosis of peripartum cardiomyopathy, chemotherapy induced cardiomyopathy, current viral myocarditis, right heart failure in absence of left-sided structural disease, pericardial constriction, genetic hypertrophic cardiomyopathy, or infiltrative cardiomyopathy including amyloidosis.
  • The presence of a mechanical assist device,
  • Scheduled for mechanical assist device or heart transplant,
  • Current angina pectoris ≥class III,
  • Requiring valvular surgery or revascularization in the upcoming 3 months or Coronary Artery Bypass Grafting (CABG) within the past 3 months,
  • Anticipated need for surgery or any other cardiovascular intervention, except implantable cardioverter defibrillator and/or cardiac resynchronization therapy, within 4 weeks,
  • Other non-cardiac conditions with limited life expectancy (≤ duration of the trial/ 1 year),
  • Participation in another clinical trial apart from non-interventional studies.
  • Patients with an unscheduled hospital visit or admission for reasons that are not primarily related to worsening of heart failure. Therefore, patients with concomitant pulmonary disease, even if severe, valvular disease, acute coronary syndrome or stroke, may be included when the primary diagnosis for admission to hospital or outpatient clinic visit has been heart failure, rather than the concomitant condition.
  • Women who are pregnant, breastfeeding or those considering becoming pregnant
  • Subjects unable to provide informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07647848 · TAILOR-HF · 101112022 · No 10088702

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗