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Tighter blood pressure target may slash heart risks in hormone disorder

NCT ID NCT07673445

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This trial compares two blood pressure targets in people with primary aldosteronism, a hormonal condition that causes high blood pressure. One group aims for a systolic pressure below 120 mmHg (intensive), the other between 120 and 140 mmHg (standard). Over 6 to 10 years, researchers track heart attacks, strokes, and other cardiovascular events to see if tighter control offers greater protection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
antihypertensive medications
What this could lead to
If intensive control works, it could establish a new, more effective blood pressure target to prevent heart attacks and strokes in people with primary aldosteronism.
What could go wrong
This is a large but early-stage comparison; intensive control may cause more side effects like dizziness or fainting, and the benefit over standard care may be small or absent.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 3,830 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \<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 Exclusion Criteria: 1. Patients with PA who are planned to undergo adrenal surgical treatment. 2. Other clearly diagnosed forms of secondary hypertension (excluding subclinical Cushing's syndrome and obstructive sleep apnea \[OSA\]). 3. Severe hypertension: systolic blood pressure (SBP) ≥190 mmHg or diastolic blood pressure (DBP) ≥110 mmHg. 4. Diastolic blood pressure \<60 mmHg (without antihypertensive medication). 5. Myocardial infarction, unstable angina, stroke, or coronary revascularization (PCI or CABG) within the past 3 months. 6. Planned coronary revascularization (PCI or CABG) within the next 6 months. 7. Severe valvular heart disease, or valvular disease likely to require surgical or percutaneous valve replacement during the study period. 8. 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. 9. NYHA functional class III-IV heart failure or left ventricular ejection fraction \<35%. 10. ALT or AST \>2.5 times the upper limit of normal, or active liver disease. 11. Dialysis dependence or eGFR \<30 mL/min/1.73 m². 12. Polycystic kidney disease or glomerulonephritis. 13. Any condition with an expected life expectancy \<5 years. 14. 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. 15. Failure to provide written informed consent. 16. Current participation in another interventional study. 17. Pregnancy, planned pregnancy, or women of childbearing potential not using effective contraception.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • the First Affiliated Hospital of Chongqing Medical University

    Chongqing, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.