Primary AldosteronismPA-PROGNCT07378176
Prognosis of Primary Aldosteronism: A Prospective Cohort Study
An observational study of Primary Aldosteronism, run by Xinjiang Medical University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Aldosteronism
- How many people
- 5,000 participants
- Where
- 2 sitesChina
- Study dates
- 30 Jan 2026to Dec 2031
- How long will I take part?
- 60 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a diagnosis of primary aldosteronism (PA) confirmed in accordance with current clinical guidelines.
Who may be able to join
- 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.
Who cannot join
- patients with severe cardiac, hepatic or renal dysfunction;
- Diagnosis of secondary hypertension other than PA.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Chengdu Medical College
Chengdu, Sichuan, 610000
Peijian Wang, PhD, +86-18980718263, wpjmed@aliyun.com
Kaige Feng, +86-17828098050, fengkaigedoc@163.com
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830000
Xiang Xie, PhD, +86-991-4366892, xiangxie999@sina.com
Changjiang Deng, +86-18139692621, 1187229853@qq.com
About this study
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.
- Conditions
- Primary Aldosteronism
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary Aldosteronism Group | Screened, confirmed and subtyped according to the guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From study enrollment until the end of the 60-month follow-up period.
Secondary outcomes (11)
All-cause mortality
Record of deaths from any cause during follow-up. Confirmed by medical records, family follow-up, or national death registration systems.
Measured: 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.
Measured: 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.
Measured: 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..
Measured: 12, 24, 36, 48, and 60 months.
Plasma Aldosterone Concentration (PAC)
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Plasma Renin Concentration (PRC)
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Serum Potassium (K+) Level
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Estimated Glomerular Filtration Rate (eGFR)
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Urinary Albumin-to-Creatinine Ratio (UACR)
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Left Ventricular Mass Index (LVMI)
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Carotid Intima-Media Thickness (CIMT)
Measured: Baseline, 12, 24, 36, 48, and 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start30 Jan 2026
- Primary completionJan 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 60 Months
Sponsor and investigators
- Lead sponsor
- Xinjiang Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Chengdu Medical College, First Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Principal investigator, Xiang Xie, Xinjiang Medical University
- Investigators
- Xiang Xie, PhD, Study chair, First Affiliated Hospital of Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378176
- Sponsor's protocol ID
- K202512-38
- Acronym
- PA-PROG
- Status last verified
- Feb 2026
- First submitted
- 22 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis of Primary Aldosteronism: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07378176
- Acronym / sponsor ID
- PA-PROG / K202512-38
- Conditions
- Primary Aldosteronism
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Xinjiang Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Chengdu Medical College, First Affiliated Hospital of Xinjiang Medical University
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 60 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary Aldosteronism Group | – | –Screened, confirmed and subtyped according to the guidelines. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of primary aldosteronism (PA) confirmed in accordance with current clinical guidelines.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- patients with severe cardiac, hepatic or renal dysfunction;
- Diagnosis of secondary hypertension other than PA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cumulative incidence of Major Adverse Cardiovascular Events (MACE)
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.
11 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiang Xie, PhD study chair
First Affiliated Hospital of Xinjiang Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Aldosteronism, run by Xinjiang Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiang Xie, PhD (+86-991-4366892, xiangxie999@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of Major Adverse Cardiovascular Events (MACE) (time frame: From study enrollment until the end of the 60-month follow-up period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2026.