Biomechanical Precision Medicine Registry for Patients With and Without 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: Heart Failure With Normal Ejection Fraction, Heart Failure With Reduced Ejection Fraction, Heart Failure, Right Sided, Heart Failure With Mid Range Ejection Fraction. 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
Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) Study
Обзор
In this single-center, longitudinal observational study, we will comprehensively examine clinical characteristics, proteomic, metabolomic, genomic and imaging data to better understand how different heart failure types may develop and progress over time. We will evaluate distinct sub-groups of heart failure (also known as heart failure phenotypes) and cardiomyopathies including amyloidosis with an ultimate goal of bringing the right medications and therapy to the right patients to optimize benefit and minimized side effects, an effort to improve precision medicine in heart failure.
Подробное описание
Patients 18-years and older with and without heart failure (across all left ventricular ejection fraction) and cardiomyopathies including amyloidosis will be enrolled in this single center, longitudinal observational Registry.
Baseline and one-year follow up blood samples including DNA as well as clinical characteristics, events leading up to heart failure diagnosis, etiology of heart failure, the presence and duration of other medical problems, laboratory, echocardiographic data and images, and therapy information will be obtained.
Clinical outcomes of interest include major adverse cardiovascular events (a combination of all-cause death and heart failure hospitalizations), individual endpoints of all-cause death, cardiovascular death, all-cause hospitalization, cardiovascular hospitalization, heart failure hospitalization, right-sided heart failure, and kidney injury.
Results from the Preserved vs. Reduced Ejection Fraction Biomarker Registry and Precision Medicine Database for Ambulatory Heart Failure Patients (PREFER-HF) trial will comprehensively examine longitudinal clinical characteristics, proteomic, metabolomic, genomic and imaging data to better understand pathophysiology of heart failure and phenotypes in heart failure with an ultimate goal of improving precision medicine in heart failure.
Первичные конечные точки
- Major adverse cardiovascular events (MACE) [Срок оценки: Time from sample collection until the date of documented event up to 60 months after the study closure.]
Вторичные конечные точки (7)
- Time to event: all-cause mortality [Срок оценки: Time from sample collection until the date of documented event up to 60 months after the study closure.]
- Time to event: cardiovascular mortality [Срок оценки: Time from sample collection until the date of documented event up to 60 months after the study closure.]
- Time to event: all-cause hospitalization [Срок оценки: Time from sample collection until the date of documented event up to 60 months after the study closure.]
- Time to event: cardiovascular hospitalization [Срок оценки: Time from sample collection until the date of documented event up to 60 months after the study closure.]
- Time to event: HF hospitalization [Срок оценки: Time from sample collection until the date of documented event up to 60 months after the study closure.]
- Time to event: Right-sided HF [Срок оценки: Time from sample collection until the date of documented event up to 60 months after the study closure.]
- Time to event: acute kidney injury [Срок оценки: Time from sample collection until the date of documented event up to 60 months after the study closure.]
Критерии участия
Inclusion criteria for patients with HF:
- 18 years and older
- History of clinical symptoms consistent with HF and at least one of the following supporting evidence of HF:
- NT-proBNP > 125 pg/mL
- BNP > 35 pg/mL
- Capillary wedge pressure ≥ 15 mmHg on right heart catheterization or CI <2.8 L/min/m2
- LVEDP ≥ 15 mmHg
- Radiographic evidence of pulmonary edema
- Improvement in symptoms with diuretic initiation of increase
- CPET evidence of cardiac etiology of symptoms
HFpEF: LVEF ≥ 50% HFrEF: LVEF <50%
Exclusion criteria (for all patients, including both those with HFpEF and HFrEF):
\- End stage renal disease on dialysis
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Massachusetts General Hospital — Boston
Публикации
- Abboud A, Nguonly A, Bean A, Brown KJ, Chen RF, Dudzinski D, Fiseha N, Joice M, Kimaiyo D, Martin M, Taylor C, Wei K, Welch M, Zlotoff DA, Januzzi JL, Gaggin HK. Rationale and design of the preserved versus reduced ejection fraction biomarker registry and precision medicine database for ambulatory patients with heart failure (PREFER-HF) study. Open Heart. 2021 Oct;8(2):e001704. doi: 10.1136/openhr PMID 34663746
Идентификаторы
NCT: NCT03480633 · 2016P000339