Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT07259733
Eligibility Criteria:
Inclusion Criteria: Age between 18 and 75 years;
Treatment with 3 to 5 classes of antihypertensive drugs, including a maximum dose of an ACE inhibitor or ARB, a thiazide or thiazide-like diuretic, and a calcium channel blocker (CCB);
Recent 24-hour ambulatory blood pressure monitoring (ABPM) (\<1 month) showing values above target (24-hour BP ≥130/80 mmHg);
Office blood pressure ≥140/90 mmHg;
Poor adherence to treatment, defined as a score ≥1 point on the Morisky Medication Adherence Scale (MMAS-4).
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Exclusion Criteria:Secondary hypertension (including hyperaldosteronism, pheochromocytoma, or renovascular hypertension);
History of intolerance or adverse reactions to study medications, such as ACE inhibitors (cough or angioedema), thiazide or thiazide-like diuretics (electrolyte disturbances), or calcium channel blockers (significant ankle edema or headache);
Indispensable use of beta-blockers or mineralocorticoid receptor antagonists;
Office blood pressure ≥ 220 × 120 mmHg;
Reduced left ventricular ejection fraction (LVEF \< 55%);
Severe renal impairment (creatinine clearance \< 30 mL/min or eGFR \< 30 mL/min/1.73 m²);
Atrial fibrillation or atrial flutter;
Use of oral anticoagulants;
Significant valvular heart disease;
Body mass index (BMI) ≥ 40 kg/m²;
Pregnant or breastfeeding women;
Severe psychiatric disorders;
Active malignancy with life expectancy \< 2 years;
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07259733
Study Brief:
Protocol Section:
NCT07259733