Меню
Набор скоро начнётся NCT07297745

Trial of Aldosterone-hybrid SteRoid for Guiding curablE Treatment of Primary Aldosteronism (TARGET-PA)

Без фазы С лечением Hyperaldosteronism; Primary Primary Aldosteronism Due to Aldosterone Producing Adenoma

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: Hybrid hormones.
Кому может быть актуально
Состояния в реестре: Hyperaldosteronism; Primary, Primary Aldosteronism Due to Aldosterone Producing Adenoma. Базовые параметры: от 21 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
Сингапур
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

The goal of this project is to improve the diagnostic pathway for patients with primary aldosteronism, by validating non-invasive biomarkers coupled with routine computed tomography imaging. The aim is to reduce reliance on invasive procedures, shorten diagnostic timelines, and enhance accessibility to definitive diagnosis and treatment globally.

Подробное описание

Primary Aldosteronism is a common but under-diagnosed condition, despite being a curable cause of secondary hypertension with significant long-term health consequences if left untreated. Once the diagnosis of primary aldosteronism is confirmed, subtype tests are required to demonstrate unilateral primary aldosteronism before curative surgery. Most patients need to undergo adrenal vein sampling, an invasive procedure performed under radiological guidance. However, this procedure is technically-challenging, with failure to cannulate both adrenal veins frequently leading to inconclusive results. Many patients worldwide may be offered surgery based on computed tomography imaging alone because of a lack of adrenal vein sampling expertise or a failed adrenal vein sampling result.

High hybrid hormones indicate a functional KCNJ5-mutant aldosterone-producing adenoma and, when coupled with computed tomography imaging, may provide a non-invasive alternative to adrenal vein sampling for identifying unilateral primary aldosteronism.

Ultimately, this trial aims to reduce the number of patients that will require an invasive adrenal vein sampling in future clinical diagnostics. This will improve access, and allow more patients to receive timely and curative treatment.

Вмешательства

  • Диагностический тест Hybrid hormones
    Participants will have a baseline blood sample taken so the investigators can measure the adrenal steroid biomarkers 18-oxocortisol, 18-hydroxylcortisol and other steroids. The collected plasma or serum will then be analyzed in the laboratory using validated methods, such as liquid chromatography-tandem mass spectrometry (LC-MS/MS), to determine the levels of these biomarkers.

Первичные конечные точки

  • Proportion of participants with complete biochemical success after unilateral adrenalectomy for unilateral primary aldosteronism using Primary Aldosteronism Surgical Outcome (PASO) measured at least six months post-adrenalectomy. [Срок оценки: 6 months]
  • Proportion of participants with KCNJ5-mutant aldosterone producing adenoma/nodule [Срок оценки: 6 months]
Вторичные конечные точки (3)
  • Proportion of participants with complete clinical success after unilateral adrenalectomy for unilateral primary aldosteronism using Primary Aldosteronism Surgical Outcome (PASO) measured at least six months post-adrenalectomy. [Срок оценки: 6 months]
  • Cost-effectiveness of using hybrid hormones coupled with computed tomography imaging versus other subtyping tests including adrenal vein sampling and/or molecular imaging in diagnosing participants with unilateral primary aldosteronism [Срок оценки: 6 months]
  • Diagnostic criteria using hybrid hormones/ steroid profiling coupled with computed tomography imaging [Срок оценки: 6 months]

Критерии участия

Критерии включения

  • Confirmed diagnosis of primary aldosteronism according to the Endocrine Society guideline 2025.
  • Willing to undergo subtype testing with adrenal vein sampling and/or molecular imaging (Positron Emission Tomography/Computed Tomography, PET/CT).
  • Keen for surgical treatment if shown to have unilateral primary aldosteronism.

Критерии исключения

  • Inability to provide written informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Сингапур · 4 центра
  • Changi General Hospital — Singapore
  • National University Hospital — Singapore
  • Sengkang General Hospital — Singapore
  • Singapore General Hospital — Singapore

Идентификаторы

NCT: NCT07297745 · TARGET-PA

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗