NCT07378176

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
68mo left

Started Jan 2026

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Jan 2026Dec 2031

First Submitted

Initial submission to the registry

January 22, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

February 3, 2026

Status Verified

February 1, 2026

Enrollment Period

4.9 years

First QC Date

January 22, 2026

Last Update Submit

February 2, 2026

Conditions

Primary Aldosteronism

Outcome Measures

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.

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

Secondary Outcomes (11)

  • All-cause mortality

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

  • Blood pressure control rate

    12, 24, 36, 48, and 60 months.

  • Incidence of new-onset atrial fibrillation (AF)

    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)

    12, 24, 36, 48, and 60 months.

  • Plasma Aldosterone Concentration (PAC)

    Baseline, 12, 24, 36, 48, and 60 months.

  • +6 more secondary outcomes

Study Arms (1)

Primary Aldosteronism Group

Screened, confirmed and subtyped according to the guidelines.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The First Affiliated Hospital of Chengdu Medical College

Chengdu, Sichuan, 610000, China

RECRUITING

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, 830000, China

RECRUITING

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System Diseases

Study Officials

  • Xiang Xie, PhD

    First Affiliated Hospital of Xinjiang Medical University

    STUDY CHAIR

Central Study Contacts

Xiang Xie, PhD

CONTACT

+86-991-4366892xiangxie999@sina.com

Changjiang Deng

CONTACT

+86-181396926211187229853@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 30, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

December 1, 2031

Last Updated

February 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(2)