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NCT07673445
Intensive vs. Standard Blood Pressure Control in Primary Aldosteronism
Conditions: Primary Aldosteronism
Sex: All
Healthy volunteers: No
Phase: NA
Enrollment: 3830
Sponsor: Chongqing Medical University
Location: the First Affiliated Hospital of Chongqing Medical University Chongqing
Summary
The goal of this clinical trial is to evaluate whether an intensive blood pressure control strategy (systolic blood pressure target \
Eligibility Criteria
Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for enrollment:
1. 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.
2. 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.
3. Increased risk of cardiovascular disease (one or more of the following):
* Previous history of clinical CVD (≥ 3 months)
* Stroke
* Myocardial infarction
* Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
* Carotid endarterectomy or carotid stenting
* Peripheral artery disease (PAD) with revascularization
* Acute coronary syndrome with or without resting ECG change, ECG changes on a graded exercise test, or positive cardiac imaging study
* Subclinical CVD within 3 years
* ≥50% stenosis of a coronary, carotid, or lower extremity artery
* Ankle brachial index (ABI) ≤0.90
* Chest pain with evidence of myocardial ischemia
* 2 or more CVD risk factors
* Male ≥50 years or female ≥55 years
* History of smoking (≥1 cigarette per day in the past 12 months)
* Diabetes mellitus
* BMI \>28 kg/m²
* Dyslipidemia despite receiving maximally tolerated statin therapy: LDL cholesterol \>130 mg/dL (\>3.36 mmol/L), or HDL cholesterol \
Source: ClinicalTrials.gov (NCT07673445). StuddyBuddy aggregates publicly available trial information.