Prognosis of Primary Aldosteronism: A Prospective Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Aldosteronism. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Primary outcome measures
- Cumulative incidence of Major Adverse Cardiovascular Events (MACE) [Time frame: From study enrollment until the end of the 60-month follow-up period.]
Secondary outcome measures (11)
- All-cause mortality [Time frame: From study enrollment until the end of the 60-month follow-up period.]
- Blood pressure control rate [Time frame: 12, 24, 36, 48, and 60 months.]
- Incidence of new-onset atrial fibrillation (AF) [Time frame: 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) [Time frame: 12, 24, 36, 48, and 60 months.]
- Plasma Aldosterone Concentration (PAC) [Time frame: Baseline, 12, 24, 36, 48, and 60 months.]
- Plasma Renin Concentration (PRC) [Time frame: Baseline, 12, 24, 36, 48, and 60 months.]
- Serum Potassium (K+) Level [Time frame: Baseline, 12, 24, 36, 48, and 60 months.]
- Estimated Glomerular Filtration Rate (eGFR) [Time frame: Baseline, 12, 24, 36, 48, and 60 months.]
- Urinary Albumin-to-Creatinine Ratio (UACR) [Time frame: Baseline, 12, 24, 36, 48, and 60 months.]
- Left Ventricular Mass Index (LVMI) [Time frame: Baseline, 12, 24, 36, 48, and 60 months.]
- Carotid Intima-Media Thickness (CIMT) [Time frame: Baseline, 12, 24, 36, 48, and 60 months.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- patients with severe cardiac, hepatic or renal dysfunction;
- Diagnosis of secondary hypertension other than PA.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 2 centers
- The First Affiliated Hospital of Chengdu Medical College — Chengdu
- The First Affiliated Hospital of Xinjiang Medical University — Ürümqi
Identifiers
NCT: NCT07378176 · K202512-38