Prognosis of Primary Aldosteronism: A Prospective Cohort Study
ConditionPrimary Aldosteronism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorXinjiang Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
patients with severe cardiac, hepatic or renal dysfunction;
Diagnosis of secondary hypertension other than PA.
Trial population
Patients with a diagnosis of primary aldosteronism (PA) confirmed in accordance with current clinical guidelines.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,000 Participants
are grouped into 1 trial groupGroup A: Primary Aldosteronism Group
Trial outcomes
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.Sponsors and contacts
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Xinjiang Medical University
Lead sponsor
First Affiliated Hospital of Chengdu Medical College
Collaborator
First Affiliated Hospital of Xinjiang Medical University
Collaborator
Source ClinicalTrials.gov