An interventional study of Intensive BP control and Standard BP control in Primary Aldosteronism, sponsored by Chongqing Medical University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Chongqing Medical University · Not applicable, Interventional, and Treatment
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.
201 studies on the registry are indexed under Hyperaldosteronism; 93 are open to participants now.
This study's planned enrollment of 3,830 is above the median of 63 across 94 interventional studies indexed under Hyperaldosteronism.
Browse Hyperaldosteronism studies →Chongqing Medical University is the lead sponsor of 78 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 .
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
Exclusion Criteria:
Factors likely to affect adherence to the intervention, including:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Intensive BP control
Drug: Standard BP control
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.
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 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).
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Dec 2036, 125 months after the start.
Of 35 interventional studies with no phase under Hyperaldosteronism, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 125 months is above that.
How these figures are worked out, and which studies are left out of them.
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Chongqing Medical University