Primary AldosteronismIntensia-AldoNCT07673445
Intensive vs. Standard Blood Pressure Control in Primary Aldosteronism
A study of Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Primary Aldosteronism
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,830 participants
- Where
- 1 siteChina
- Study dates
- 7 Jul 2026to Dec 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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):
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- 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 <40 mg/dL (<1.03 mmol/L) in males or <50 mg/dL (<1.29 mmol/L) in females
- Family history of premature coronary heart disease (defined as myocardial infarction or coronary revascularization) in a first-degree relative: male relative <55 years or female relative <65 years
- Microalbuminuria (Note: If microalbuminuria is the only criterion, a repeat test is required for confirmation)
- Estimated glomerular filtration rate (eGFR) 30-59 ml/min/1.73 m²
Who cannot join
- 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.
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- 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:
- Alcohol abuse or drug abuse within the past 12 months.
- History of severe non-adherence to medication or follow-up.
- Residence far from the study center or planned relocation within 5 years.
- Clinical diagnosis or treatment of dementia, or cognitive impairment preventing adherence to the protocol.
- Other medical, psychiatric, or behavioral factors that may interfere with study participation.
- Failure to provide written informed consent.
- Current participation in another interventional study.
- Pregnancy, planned pregnancy, or women of childbearing potential not using effective contraception.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Chongqing Medical University
Chongqing
Ying Jing, +86-18523915303, 1074334870@qq.com
Qifu Li, phD
About this study
Official title: Intensive Versus Standard Blood Pressure Control in Patients With Primary Aldosteronism (Intensia-Aldo): A Multi-center, Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Primary Aldosteronism
- Being tested
- Intensive BP control, Standard BP control
- Keywords
- treatment, intensive blood pressure control
- Medical subject headings
- Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive BP controlDrug
Adjusting antihypertensive medications keeps the patient's systolic blood pressure controlled at below 120 mmHg.
Standard BP controlDrug
Adjusting antihypertensive medications keeps the patient's systolic blood pressure controlled between 120 and 140 mmHg.
| Study group | Role | What they receive |
|---|---|---|
| Intensive treatment group | Experimental | Not described Receives: Drug: Intensive BP control |
| Standard treatment group | Active comparator | Not described Receives: Drug: Standard BP control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Secondary outcomes (13)
Expanded Outcome (Primary Outcome + All-Cause Death)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start7 Jul 2026
- Primary completionDec 2036 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary AldosteronismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either an intensive treatment group or a standard treatment group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 3,830 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qifu Li, First Affiliated Hospital of Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673445
- Sponsor's protocol ID
- Intensia-Aldo
- Acronym
- Intensia-Aldo
- Status last verified
- May 2026
- First submitted
- 27 May 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Versus Standard Blood Pressure Control in Patients With Primary Aldosteronism (Intensia-Aldo): A Multi-center, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07673445
- Acronym / sponsor ID
- Intensia-Aldo / Intensia-Aldo
- Conditions
- Primary Aldosteronism
- Keywords
- treatment, intensive blood pressure control
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,830 participants (estimated)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Chongqing Medical University
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- Dec 2036 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to either an intensive treatment group or a standard treatment group.
| Arm | Type | Receives |
|---|---|---|
| Intensive treatment group | Experimental | Drug: Intensive BP control |
| Standard treatment group | Active comparator | Drug: Standard BP control |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (26 listed)
- 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):
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive BP controlAdjusting antihypertensive medications keeps the patient's systolic blood pressure controlled at below 120 mmHg. | Drug | Intensive treatment group |
| Standard BP controlAdjusting antihypertensive medications keeps the patient's systolic blood pressure controlled between 120 and 140 mmHg. | Drug | Standard treatment group |
Primary outcome
Primary Outcome: The number of composite cardiovascular events that occurred
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).
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.
13 secondary outcomes
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
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
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Primary Aldosteronism, run by Chongqing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qifu Li, phD (+86-18696676815, liqifu@yeah.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome: The number of composite cardiovascular events that occurred (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.