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| Name | Class |
|---|---|
| First Affiliated Hospital of Chongqing Medical University | OTHER |
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The goal of this clinical trial is to evaluate whether an intensive blood pressure control strategy (systolic blood pressure target <120 mmHg) is more effective than a standard strategy (systolic blood pressure target <140 mmHg) in reducing the risk of cardiovascular events in patients with primary aldosteronism.
The main question it aims to answer is: Does the intensive blood pressure control strategy reduce the risk of composite cardiovascular events more than the standard strategy in patients with primary aldosteronism? The study employs a randomized design, allocating participants in a 1:1 ratio to either the Intensive Treatment Group or the Standard Treatment Group. Researchers will compare the differences in cardiovascular outcomes and safety profiles between the two groups over a planned follow-up period of 6 to 10 years.
Participants will:
Undergo randomization and adhere to the assigned blood pressure management protocol.
Attend regular follow-up visits for blood pressure measurement, laboratory tests, questionnaires, etc.
Report any adverse events or changes in health status.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive treatment group | Experimental |
| |
| Standard treatment group | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive BP control | Drug | Adjusting antihypertensive medications keeps the patient's systolic blood pressure controlled at below 120 mmHg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Outcome: The number of composite cardiovascular events that occurred | A composite of major cardiovascular events, including nonfatal myocardial infarction, unstable angina, nonfatal stroke, hospitalization or treatment for heart failure, atrial fibrillation, coronary or non-coronary revascularization, and cardiovascular death. | Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated follow-up: 6-10 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Expanded Outcome (Primary Outcome + All-Cause Death) | Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated follow-up: 6-10 years). | |
| Major Coronary Artery Disease (Non-fatal myocardial infarction, Unstable angina, Coronary revascularization, Death from coronary heart disease) |
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Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for enrollment:
A diagnosis of PA meeting the following criteria: an upright plasma aldosterone-to-renin ratio (ARR) ≥20 (pg/mL)/(μIU/mL) or ≥300 (pg/mL)/(ng/mL/h); and at least one positive confirmatory test: plasma aldosterone ≥110 pg/mL after the captopril challenge test (CCT) or plasma aldosterone ≥80 pg/mL after the seated saline infusion test (SSIT).
Note: For patients with an upright ARR ratio between 10-20 (pg/mL)/(μIU/mL), the screening result can also be considered positive if they have additional high-risk factors such as adrenal lesions or resistant hypertension. Patients receiving medications that may suppress renin and lead to false-positive results (e.g., β-adrenergic blockers and centrally acting α₂-agonists such as clonidine or α-methyldopa) should discontinue these medications and repeat testing after a 2-week washout period.
Systolic blood pressure of 140-190 mmHg (or currently receiving antihypertensive treatment).
Notes: (1) Office mean seated blood pressure is defined as the average of three seated blood pressure measurements obtained at any single on-site visit. (2) There is no diastolic blood pressure criterion for inclusion.
Increased risk of cardiovascular disease (one or more of the following):
Previous history of clinical CVD (≥ 3 months)
Subclinical CVD within 3 years
2 or more CVD risk factors
Estimated glomerular filtration rate (eGFR) 30-59 ml/min/1.73 m²
Exclusion Criteria:
Patients with PA who are planned to undergo adrenal surgical treatment.
Other clearly diagnosed forms of secondary hypertension (excluding subclinical Cushing's syndrome and obstructive sleep apnea [OSA]).
Severe hypertension: systolic blood pressure (SBP) ≥190 mmHg or diastolic blood pressure (DBP) ≥110 mmHg.
Diastolic blood pressure <60 mmHg (without antihypertensive medication).
Myocardial infarction, unstable angina, stroke, or coronary revascularization (PCI or CABG) within the past 3 months.
Planned coronary revascularization (PCI or CABG) within the next 6 months.
Severe valvular heart disease, or valvular disease likely to require surgical or percutaneous valve replacement during the study period.
Hypertrophic cardiomyopathy (HCM). Definition: A disease characterized by unexplained left ventricular hypertrophy, with a non-dilated ventricular cavity and absence of other cardiac or systemic diseases. Clinically, HCM is usually diagnosed by echocardiography, defined as a maximum left ventricular wall thickness ≥15 mm, or 13-14 mm (considered borderline), particularly in the presence of additional supporting evidence (e.g., a family history of HCM). In elderly patients with left ventricular hypertrophy and a long-standing history of systemic hypertension, a diagnosis of HCM may be established if a definite sarcomeric gene mutation is identified, or if left ventricular wall thickness is markedly >25 mm and/or there is left ventricular outflow tract obstruction with systolic anterior motion of the mitral valve and mitral valve-septal contact.
NYHA functional class III-IV heart failure or left ventricular ejection fraction <35%.
ALT or AST >2.5 times the upper limit of normal, or active liver disease.
Dialysis dependence or eGFR <30 mL/min/1.73 m².
Polycystic kidney disease or glomerulonephritis.
Any condition with an expected life expectancy <5 years.
Factors likely to affect adherence to the intervention, including:
Failure to provide written informed consent.
Current participation in another interventional study.
Pregnancy, planned pregnancy, or women of childbearing potential not using effective contraception.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qifu Li, phD | Contact | +86-18696676815 | liqifu@yeah.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Chongqing Medical University | Chongqing | China |
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| ID | Term |
|---|---|
| D006929 | Hyperaldosteronism |
| ID | Term |
|---|---|
| D000308 | Adrenocortical Hyperfunction |
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
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Participants will be randomly assigned in a 1:1 ratio to either an intensive treatment group or a standard treatment group.
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| Standard BP control | Drug | Adjusting antihypertensive medications keeps the patient's systolic blood pressure controlled between 120 and 140 mmHg. |
|
| Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated follow-up: 6-10 years). |
| Total Myocardial Infarction (Fatal and Non-fatal) | Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631events are reached (anticipated follow-up: 6-10 years). |
| Total Stroke (Fatal and Non-fatal) | Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631events are reached (anticipated follow-up: 6-10 years). |
| Ischemic Stroke | Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated follow-up: 6-10 years). |
| Hemorrhagic Stroke | Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated follow-up: 6-10 years). |
| Heart Failure Requiring Hospitalization/Treatment or Death from Heart Failure | Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated median follow-up: 6-10 years). |
| Atrial fibrillation | Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated follow-up: 6-10 years). |
| Revascularization (Including Coronary and Non-Coronary) | Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated follow-up: 6-10 years). |
| cardiovascular death | Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated follow-up: 6-10 years). |
| All-Cause Death | Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated follow-up: 6-10 years). |
| Health-Related Quality of Life | Patient-reported quality of life measured via the validated SF-36 questionnaire. The overall summary score ranges from 0 (worst imaginable health) to 100 (perfect health); higher scores reflect superior health-related quality of life. Assessed at scheduled follow-up visits throughout study follow-up. | Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated follow-up: 6-10 years) |
| Number of participants with adjudicated renal composite events (CKD progression, new-onset CKD, new-onset albuminuria) assessed via serial serum creatinine and urine ACR laboratory testing | CKD progression: defined as a decline in eGFR of ≥50%, progression to end-stage kidney disease (requiring dialysis or kidney transplantation), or eGFR <15 ml/min/1.73 m², confirmed by two laboratory measurements. New-onset CKD: defined as a decline in eGFR of >30% with eGFR <60 ml/min/1.73 m², requiring confirmation. New-onset proteinuria: defined as an increase in urine albumin-to-creatinine ratio (ACR) from <30 mg/g to >30 mg/g, requiring confirmation. | Time from randomization to first occurrence of any component of the composite cardiovascular endpoint, assessed throughout the study until 631 events are reached (anticipated follow-up: 6-10 years). |