NCT Number: NCT07378176
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.
Interested in participating?
Request Info18 year–80 year
All sexes
Observational
The First Affiliated Hospital of Chengdu Medical College, Chengdu, Sichuan, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From study enrollment until the end of the 60-month follow-up period.
The proportion of patients who experience an adjudicated Major Adverse Cardiovascular Event (MACE), defined as a composite endpoint consisting of non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, or cardiovascular death.
Time frame: From study enrollment until the end of the 60-month follow-up period.
Record of deaths from any cause during follow-up. Confirmed by medical records, family follow-up, or national death registration systems.
Time frame: 12, 24, 36, 48, and 60 months.
Proportion of participants achieving target office blood pressure at each visit. Target is defined as seated systolic BP < 140 mmHg and diastolic BP < 90 mmHg. For participants with diabetes mellitus or chronic kidney disease, the target is seated systolic BP < 130 mmHg and diastolic BP < 80 mmHg.
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.
The proportion of participants newly diagnosed with atrial fibrillation. Diagnosis requires confirmation by 12-lead electrocardiogram or at least 30 seconds of AF on a 24-hour Holter monitor, as documented in medical records.
Time frame: 12, 24, 36, 48, and 60 months.
Proportion of participants with Mild Cognitive Impairment（MCI） or all-cause dementia at follow-up visits..
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Time frame: Baseline, 12, 24, 36, 48, and 60 months.
Contact information is provided by the study sponsor or research team.
Changjiang Deng
CONTACT
Xiang Xie, PhD
CONTACT
Xinjiang Medical University
Other
Acronym: PA-PROG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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