Intensive vs. Standard Blood Pressure Control in Primary Aldosteronism

NCT07673445 | Not Yet Recruiting DMC

• 1 other identifier: Intensia-Aldo
• Study Type: interventional
• Target: 3,830
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Primary Aldosteronism

Keywords

treatment; intensive blood pressure control

Outcome Measures

Primary Outcomes (1)

• 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 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)

  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 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 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 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 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).

Study Arms (2)

Intensive treatment group

EXPERIMENTAL

Drug: Intensive BP control

Standard treatment group

ACTIVE COMPARATOR

Drug: Standard BP control

Interventions

Standard BP control DRUG

Adjusting antihypertensive medications keeps the patient's systolic blood pressure controlled between 120 and 140 mmHg.

Standard treatment group

Intensive BP control DRUG

Adjusting antihypertensive medications keeps the patient's systolic blood pressure controlled at below 120 mmHg.

Intensive treatment group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Chongqing Medical University: lead
• First Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (1)

the First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Central Study Contacts

Qifu Li, phD

CONTACT

+86-18696676815; liqifu@yeah.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: Participants will be randomly assigned in a 1:1 ratio to either an intensive treatment group or a standard treatment group.

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 29, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2036
• Study Completion (Estimated): December 1, 2036
• Last Updated: June 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)