Prognosis of Primary Aldosteronism: A Prospective Cohort Study (PA-PROG)

Xinjiang Medical University

Status: Enrolling

Conditions: Primary Aldosteronism

Study type: Observational

Funder types: Other

Identifiers

NCT07378176

K202512-38

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

5,000 participants in 1 patient group

Primary Aldosteronism Group

Description:

Screened, confirmed and subtyped according to the guidelines.