Fast control of resistant high blood pressure in Brazil's public health system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center, open-label, randomized (1:1) trial at Instituto Dante Pazzanese de Cardiologia compares a fixed-dose triple pill (perindopril 10 mg, indapamide 2.5 mg, amlodipine 10 mg once daily) to usual care with up to five separate antihypertensive drugs in adults with apparent resistant hypertension. Eligible participants are 18–75 years old, treated with 3–5 antihypertensive classes including an ACE inhibitor or ARB, a thiazide or thiazide-like diuretic, and a long-acting calcium channel blocker, with uncontrolled 24-hour ABPM (≥130/80 mmHg). The primary outcome is 24-hour blood pressure control measured by ambulatory blood pressure monitoring at 12 weeks. The trial excludes patients with secondary hypertension, major contraindications to study drugs, an indispensable need for beta-blockers or mineralocorticoid receptor antagonists, or severe comorbidities.

Why it matters

Who can join: the full rules

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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Where it's running

• Instituto Dante Pazzanese de Cardiologia
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Study coordinator: Antonio G Laurinavicius, MD, PhD
• Email: antonio.laurinavicius@gmail.com
• Phone: 5511996695389

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.