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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
3,830
Adjusting antihypertensive medications keeps the patient's systolic blood pressure controlled at below 120 mmHg.
Adjusting antihypertensive medications keeps the patient's systolic blood pressure controlled between 120 and 140 mmHg.
the First Affiliated Hospital of Chongqing Medical University
Chongqing, China
RECRUITINGPrimary 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 frame: 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).
Expanded Outcome (Primary Outcome + All-Cause Death)
Time frame: 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)
Time frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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 frame: 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).
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