Intensive vs. Standard Blood Pressure Control in Primary Aldosteronism

Официальное название

Intensive Versus Standard Blood Pressure Control in Patients With Primary Aldosteronism (Intensia-Aldo): A Multi-center, Randomized Controlled Trial

Обзор

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.

Вмешательства

• Препарат Intensive BP control
  Adjusting antihypertensive medications keeps the patient's systolic blood pressure controlled at below 120 mmHg.
• Препарат Standard BP control
  Adjusting antihypertensive medications keeps the patient's systolic blood pressure controlled between 120 and 140 mmHg.

Первичные конечные точки

• Primary Outcome: The number of composite cardiovascular events that occurred [Срок оценки: 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).]

Вторичные конечные точки (12)

• Expanded Outcome (Primary Outcome + All-Cause Death) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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)]

Критерии участия

Критерии включения

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):

• 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

Критерии исключения

• 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.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• the First Affiliated Hospital of Chongqing Medical University — Чунцин

Идентификаторы

NCT: NCT07673445 · Intensia-Aldo

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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