Primary Aldosteronism in Western Norway
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: Hyperaldosteronism. Базовые параметры: 18 лет — 85 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
- Норвегия
- 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
Primary Aldosteronism: a Study of Diagnostic Approach and Treatment Outcome in Western Norway
Обзор
In this study the investigators aim to identify and include consecutively patients with primary aldosteronism (PA) diagnosed in the Western and Mid-parts of Norway, to describe the characteristics of these patients, to explore the cardiac effects of PA before and after specific treatment, and to identify long-term outcomes after treatment. One subgroup of the PA patients perform echocardiography to assess left ventricular systolic myocardial function before and after treatment. One subgroup of PA patients perform cardiac MRI to assess myocardial mass, myocardial fibrosis and myocardial function in rest and during stress, before and after treatment. For the cardiac MRI substudy, the PA patients are compared with a group of healthy controls, also included in the study. From 2022 onwards, PA patients diagnosed or subtyped with adrenal vein sampling at Oslo University Hospital will additionally be included in the study, thereby providing a national registration of PA patients.
Подробное описание
From June 2013, all newly diagnosed patients with primary aldosteronism (PA) either diagnosed at Haukeland University Hospital (HUS) or admitted to HUS for subtype testing with adrenal vein sampling, have been asked for inclusion in the study. All included patients have a base-line study visit where clinical information is registered, and baseline blood and urine samples are collected. Echocardiography will be performed in a subgroup of patients before and 1 year after start of specific PA treatment. After start of definite medical or surgical treatment the patients are followed up with regularly new study visits. From 2025 onwards, PA patients diagnosed or subtyped with adrenal vein sampling at Oslo University Hospital will additionally be included in the study, thereby providing a national registration of PA patients.
A subgroup of the included PA study patients also perform a Cardiac MRI. Cine-MRI, velocity-encoded MRI, MRI images during continuous adenosine infusion and MRI images after gadolinium contrast injection are performed, and compared to a group of age- and sex-matched healthy controls.
From 2025 onwards, PA patients either diagnosed or performing subtyping with adrenal vein sampling at Oslo University Hospital will likewise be asked for study inclusion.
Первичные конечные точки
- Long-term clinical outcome after surgical and medical treatment of PA [Срок оценки: 5 years]
- Long-term biochemical outcome after surgical treatment of PA [Срок оценки: 5 years]
Вторичные конечные точки (7)
- Echocardiographic assessment of left ventricular mass in PA patients before and after treatment [Срок оценки: 3 years]
- Echocardiographic assessment of left ventricular systolic function measured as global longitudinal strain in PA patients before and after treatment [Срок оценки: 3 years]
- Echocardiographic assessment of left ventricular systolic function measured as midwall shortening in PA patients before and after treatment [Срок оценки: 3 years]
- Incidence of reduced quality of life in PA patients before and after treatment, assessed by Short Form Health Surveys (SF-36/RAND-36) [Срок оценки: 5 years]
- Cardiac MRI assessment of left ventricular mass in PA patients before and after treatment [Срок оценки: 3 years]
- Cardiac MRI assessment of myocardial fibrosis in PA patients compared with healthy controls [Срок оценки: 3 years]
- Cardiac MRI assessment of left coronary flow reserve [Срок оценки: 3 years]
Критерии участия
Критерии включения
- Verified diagnosis or strong suspicion of primary aldosteronism
- Age 18-85
Критерии исключения
- Active cancer disease at time of inclusion
Exclusion criteria for subgroup of primary aldosteronism-patients and healthy controls who perform cardiac MRI:
- Asthma/chronic obstructive pulmonary disease ,
- Use of dipyridamole
- Claustrophobia
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Норвегия · 2 центра
- Haukeland University Hospital — Bergen
- Oslo University Hospital — Oslo
Идентификаторы
NCT: NCT02832388 · 2013/742