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RecruitingNCT07378176PA-PROGUpdated Feb 3, 2026

Prognosis of Primary Aldosteronism: A Prospective Cohort Study

An observational study in Primary Aldosteronism, sponsored by Xinjiang Medical University. Recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by Xinjiang Medical University · Observational

From the registry’s dates

  • Started Jan 2026; still recruiting 9 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Primary Aldosteronism

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03

In context

Hyperaldosteronism

201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.

This study's planned enrollment of 5,000 is above the median of 200 across 103 observational studies indexed under Hyperaldosteronism.

Browse Hyperaldosteronism studies →

Lead sponsor

Xinjiang Medical University is the lead sponsor of 21 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  1. patients with severe cardiac, hepatic or renal dysfunction;
  2. Diagnosis of secondary hypertension other than PA.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Target follow-up
60 Months
Patient registry
Yes

Groups and cohorts

  • Primary Aldosteronism Group

    Screened, confirmed and subtyped according to the guidelines.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From study enrollment until the end of the 60-month follow-up period.

Secondary outcomes

  1. All-cause mortality

    Record of deaths from any cause during follow-up. Confirmed by medical records, family follow-up, or national death registration systems.

    Time frame: From study enrollment until the end of the 60-month follow-up period.

  2. 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.

    Time frame: 12, 24, 36, 48, and 60 months.

  3. 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.

    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.

  4. 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..

    Time frame: 12, 24, 36, 48, and 60 months.

  5. Plasma Aldosterone Concentration (PAC)

    Time frame: Baseline, 12, 24, 36, 48, and 60 months.

  6. Plasma Renin Concentration (PRC)

    Time frame: Baseline, 12, 24, 36, 48, and 60 months.

  7. Serum Potassium (K+) Level

    Time frame: Baseline, 12, 24, 36, 48, and 60 months.

  8. Estimated Glomerular Filtration Rate (eGFR)

    Time frame: Baseline, 12, 24, 36, 48, and 60 months.

  9. Urinary Albumin-to-Creatinine Ratio (UACR)

    Time frame: Baseline, 12, 24, 36, 48, and 60 months.

  10. Left Ventricular Mass Index (LVMI)

    Time frame: Baseline, 12, 24, 36, 48, and 60 months.

  11. Carotid Intima-Media Thickness (CIMT)

    Time frame: Baseline, 12, 24, 36, 48, and 60 months.

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07378176
Lead sponsor
Xinjiang Medical University
Collaborators
First Affiliated Hospital of Chengdu Medical College, First Affiliated Hospital of Xinjiang Medical University
Responsible party
Xiang Xie (Professor, Xinjiang Medical University) — Principal investigator
First posted
Jan 30, 2026
Start date
Jan 30, 2026
Primary completion
Jan 2031 (estimated)
Completion
Dec 2031 (estimated)
Last update
Feb 3, 2026

Study contacts

Xiang Xie, PhD
Contact
xiangxie999@sina.com
+86-991-4366892
Changjiang Deng
Contact
1187229853@qq.com
+86-18139692621
Xiang Xie, PhD
study chair · First Affiliated Hospital of Xinjiang Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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