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Идёт набор NCT07378176

Prognosis of Primary Aldosteronism: A Prospective Cohort Study

— Наблюдательное Primary Aldosteronism

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: Primary Aldosteronism. Базовые параметры: 18 лет — 80 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

Primary aldosteronism (PA) is the most common cause of secondary hypertension, and patients with PA have a significantly higher risk of developing cardiovascular and renal complications compared with those with essential hypertension. However, PA remains substantially underdiagnosed and undertreated in clinical practice, and relevant research data on the short-term and long-term prognosis of PA patients in the Chinese population are particularly scarce. This is a multicenter, prospective cohort study designed to systematically collect real-world clinical data of PA patients, including baseline clinical characteristics, etiological subtypes, diagnostic and therapeutic strategies, and long-term follow-up outcomes. Through 5 years of standardized follow-up, this study will analyze the differences in treatment efficacy among PA patients with different pathological subtypes (e.g., adrenal adenoma, adrenal hyperplasia), evaluate the short-term therapeutic efficacy and long-term prognosis of PA patients undergoing different treatment modalities including pharmacotherapy, surgery and interventional therapy, and explore the risk factors for adverse clinical outcomes. Ultimately, it will provide high-quality real-world evidence-based data to optimize the clinical diagnosis and management of PA and improve the long-term prognosis of affected patients.

Подробное описание

This study conducts long-term follow-up observations on patients with primary aldosteronism (PA), dynamically tracks changes in their condition, and systematically collects information related to treatment regimens and health outcomes, aiming to ultimately achieve the following research objectives: clarify the proportion and regularity of PA patients achieving normalization of both blood pressure and relevant hormonal levels after treatment (i.e., the status of "complete cure"); analyze differences in therapeutic efficacy among PA patients with different pathological subtypes such as adrenal adenoma and adrenal hyperplasia; evaluate the impact of different treatment modalities including pharmacotherapy, surgery and interventional therapy on patients' long-term health; observe the trajectory changes of PA-induced damage to the heart, kidneys and blood vessels, as well as metabolic and cognitive function abnormalities; and screen for key factors influencing patients' blood pressure control efficacy and the occurrence of cardiovascular and cerebrovascular events.

Первичные конечные точки

  • Cumulative incidence of Major Adverse Cardiovascular Events (MACE) [Срок оценки: From study enrollment until the end of the 60-month follow-up period.]
Вторичные конечные точки (11)
  • All-cause mortality [Срок оценки: From study enrollment until the end of the 60-month follow-up period.]
  • Blood pressure control rate [Срок оценки: 12, 24, 36, 48, and 60 months.]
  • Incidence of new-onset atrial fibrillation (AF) [Срок оценки: From study enrollment until the end of the 60-month follow-up period. Routine screening ECGs will be performed at 12, 24, 36, 48, and 60 months.]
  • Incidence of cognitive impairment(Mild Cognitive Impairment or dementia) [Срок оценки: 12, 24, 36, 48, and 60 months.]
  • Plasma Aldosterone Concentration (PAC) [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]
  • Plasma Renin Concentration (PRC) [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]
  • Serum Potassium (K+) Level [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]
  • Estimated Glomerular Filtration Rate (eGFR) [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]
  • Urinary Albumin-to-Creatinine Ratio (UACR) [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]
  • Left Ventricular Mass Index (LVMI) [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]
  • Carotid Intima-Media Thickness (CIMT) [Срок оценки: Baseline, 12, 24, 36, 48, and 60 months.]

Критерии участия

Критерии включения

  • Aged between 18 and 80 years old.
  • Biochemically confirmed diagnosis of Primary Aldosteronism (PA) according to contemporary guidelines (e.g., confirmed positive case detection test and confirmatory test).
  • Voluntary to sign the informed consent.

Критерии исключения

  • patients with severe cardiac, hepatic or renal dysfunction;
  • Diagnosis of secondary hypertension other than PA.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 2 центра
  • The First Affiliated Hospital of Chengdu Medical College — Чэнду
  • The First Affiliated Hospital of Xinjiang Medical University — Ürümqi

Идентификаторы

NCT: NCT07378176 · K202512-38

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗