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Recruiting 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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07673445). StuddyBuddy aggregates publicly available trial information.