The Plasma Metabolomics Profiling of Primary Aldosteronism

Third Military Medical University

Status: Completed

Conditions: Essential Hypertension; Primary Aldosteronism; Aldosterone-producing Adenoma; Idiopathic Aldosteronism

Treatments: Diagnostic Test: liquid chromatography-mass spectrometry (LC/MS)

Study type: Observational

Funder types: Other

Identifiers

NCT06500000

MP of PA

Details and patient eligibility

About

Primary aldosteronism (PA), characterized by overt renin-independent aldosterone production, is the most common form endocrine hypertension. Compared with blood pressure-matched cases of essential hypertension (EH), PA is associated with a higher risk of cardiovascular morbidity and mortality. It is estimated that PA affects at least 10% of hypertensive patients and up to 25% of treatment-resistant hypertension. The major subtypes of PA are comprised of bilateral idiopathic hyperaldosteronism (IHA) and unilateral aldosterone-producing adenoma (APA). The screening, confirmatory testing, and subtype differentiation of PA for therapeutic management is a multi-step and complex process, resulting in low screening rates and poor clinical recognition.

PA is an independent risk factor for metabolic morbidity. Metabolomic profiling is a relatively new strategy for the diagnosis and prognosis of disease through identification and quantification of various metabolites. In the current study, we aimed to investigate the potential biomakers for discriminating PA from EH, as well as subtype classification for PA, by untargeted metabolomics.

Enrollment: 95 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• According to 2010 Chinese guidelines for the management of Essential hypertension (EH), EH was defined as systolic blood pressure (SBP) ≥140 mm Hg, diastolic blood pressure (DBP) ≥90 mm Hg, and use of antihypertensive medicine within 2 weeks and excluded from PA through ARR or confirmatory testing.
• Patients were confirmed to be diagnosed with Primary aldosteronism (PA) in accordance with the Endocrine Society Clinical Practice Guideline criteria. Patients with an aldosterone-to-renin ratio (ARR) > 3.7 (ng/dL) further conformed with one of the following confirmatory tests: saline infusion test or captopril-inhibition test. Adrenal CT scans and Adrenal venous sampling (AVS) were performed for PA subtype classification.
• Patients with idiopathic hyperaldosteronism (IHA) were determined based on the absence of obvious adenoma on adrenal CT and bilateral aldosterone overproduction.
• Patients with aldosterone-producing adenoma (APA) were identified based on macroadenoma >1 cm on adrenal CT, unilateral hypersecretion of aldosterone, and pathological confirmation.
• Signed informed consent and agreed to participate in this study.

Exclusion criteria

• other subtypes of secondary hypertension, including renal hypertension, renovascular hypertension, and adrenal hypertension (i.e., pheochromocytoma and Cushing syndrome).
• adrenal cortical carcinoma
• acute infection at the time of assessment
• severe cardiovascular or cerebrovascular disease, liver or renal dysfunction, tumors, autoimmune disease or mental disorders.
• history of adrenalectomy
• alcohol abuse or pregnancy

Trial design

95 participants in 3 patient groups

essential hypertension (EH)

Description:

According to 2010 Chinese guidelines for the management of essential hypertension (EH), EH was defined as systolic BP (SBP) ≥140 mm Hg, diastolic BP (DBP) ≥90 mm Hg, and use of antihypertensive medicine within 2 weeks and excluded from PA through ARR or diagnostic testing.

Treatment:

Diagnostic Test: liquid chromatography-mass spectrometry (LC/MS)

idiopathic aldosteronism (IHA)

Description:

Patients were confirmed to be diagnosed with primary aldosteronism (PA) in accordance with the Endocrine Society Clinical Practice Guideline criteria. Antihypertensive drugs that may affect the renin-angiotensin-aldosterone system (RAAS) were discontinued for at least 2-4 weeks. Patients with an aldosterone-to-renin ratio (ARR) \> 3.7 (ng/dL) further underwent one of the following confirmatory tests: saline infusion test (infusion of 2 L isotonic saline within 4 h) or captopril-inhibition test (oral administration of 50 mg captopril). Adrenal CT scan and adrenal vein sampling (AVS) were performed for PA subtype classification. Patients with IHA were determined based on the absence of obvious adenoma on adrenal CT and bilateral aldosterone overproduction.

Treatment:

Diagnostic Test: liquid chromatography-mass spectrometry (LC/MS)

aldosterone-producing adenoma (APA)

Description:

Patients were confirmed to be diagnosed with primary aldosteronism (PA) in accordance with the Endocrine Society Clinical Practice Guideline criteria. Antihypertensive drugs that may affect the renin-angiotensin-aldosterone system (RAAS) were discontinued for at least 2-4 weeks. Patients with an aldosterone-to-renin ratio (ARR) \> 3.7 (ng/dL) further underwent one of the following confirmatory tests: saline infusion test (infusion of 2 L isotonic saline within 4 h) or captopril-inhibition test (oral administration of 50 mg captopril). Adrenal CT scan and adrenal vein sampling (AVS) were performed for PA subtype classification. Patients with APA were identified based on macroadenoma \>1 cm on adrenal CT, unilateral hypersecretion of aldosterone, and pathological confirmation.

Treatment:

Diagnostic Test: liquid chromatography-mass spectrometry (LC/MS)