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Rapid Management of Resistant Hypertension in the Public Health System (Fast Control)

RecruitingNAAges 18 Years - 75 YearsAllInstituto Dante Pazzanese de Cardiologia
NCT07259733 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a single-center, open-label, randomized clinical trial conducted at the Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. The study evaluates a simplified treatment strategy for patients with apparent resistant hypertension, comparing fixed triple combination therapy (perindopril, indapamide, and amlodipine) with usual care using multiple separate antihypertensive drugs. The primary objective is to compare 24-hour blood pressure control as measured by ABPM at 12 weeks between the two treatment strategies. Enrollment began on July 15, 2023, and this study was registered retrospectively.

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📋 Eligibility rules (as published)
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). \- 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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What it tests

  • Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine)
  • Usual Care Antihypertensive Regimen
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Where

1 site
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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