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

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Aldosteronism

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.

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Xiang Xie, PhD; Phone Number: +86-991-4366892; Email: xiangxie999@sina.com
• Study Contact Backup: Name: Changjiang Deng; Phone Number: +86-18139692621; Email: 1187229853@qq.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610000
      • Recruiting
      • The First Affiliated Hospital of Chengdu Medical College
      • Contact: Kaige Feng; Phone Number: +86-17828098050; Email: fengkaigedoc@163.com
      • Contact: Peijian Wang, PhD; Phone Number: +86-18980718263; Email: wpjmed@aliyun.com
  • Xinjiang
    • Ürümqi, Xinjiang, China, 830000
      • Recruiting
      • The First Affiliated Hospital of Xinjiang Medical University
      • Contact: Xiang Xie, PhD; Phone Number: +86-991-4366892; Email: xiangxie999@sina.com
      • Contact: Changjiang Deng; Phone Number: +86-18139692621; Email: 1187229853@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of primary aldosteronism (PA) confirmed in accordance with current clinical guidelines.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Primary Aldosteronism Group; Screened, confirmed and subtyped according to the guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of Major Adverse Cardiovascular Events (MACE)	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.	From study enrollment until the end of the 60-month follow-up period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Record of deaths from any cause during follow-up. Confirmed by medical records, family follow-up, or national death registration systems.	From study enrollment until the end of the 60-month follow-up period.
Blood pressure control rate	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.	12, 24, 36, 48, and 60 months.
Incidence of new-onset atrial fibrillation (AF)	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.	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)	Proportion of participants with Mild Cognitive Impairment（MCI） or all-cause dementia at follow-up visits..	12, 24, 36, 48, and 60 months.
Plasma Aldosterone Concentration (PAC)		Baseline, 12, 24, 36, 48, and 60 months.
Plasma Renin Concentration (PRC)		Baseline, 12, 24, 36, 48, and 60 months.
Serum Potassium (K+) Level		Baseline, 12, 24, 36, 48, and 60 months.
Estimated Glomerular Filtration Rate (eGFR)		Baseline, 12, 24, 36, 48, and 60 months.
Urinary Albumin-to-Creatinine Ratio (UACR)		Baseline, 12, 24, 36, 48, and 60 months.
Left Ventricular Mass Index (LVMI)		Baseline, 12, 24, 36, 48, and 60 months.
Carotid Intima-Media Thickness (CIMT)		Baseline, 12, 24, 36, 48, and 60 months.

Collaborators and Investigators

• Sponsor: Xinjiang Medical University
• Collaborators: First Affiliated Hospital of Xinjiang Medical University; First Affiliated Hospital of Chengdu Medical College
• Investigators: Study Chair: Xiang Xie, PhD, First Affiliated Hospital of Xinjiang Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): February 3, 2026
• Last Update Submitted That Met QC Criteria: February 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases; Adrenocortical Hyperfunction; Hyperaldosteronism
• Other Study ID Numbers: K202512-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No