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

Strategy for Rapid Control of Apparent Resistant Arterial Hypertension in the Public Health System (FAST Control)

This will see if a single-pill triple combination (perindopril, indapamide, amlodipine) controls blood pressure better than usual separate-pill regimens in adults with apparent resistant hypertension.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 142 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Instituto Dante Pazzanese de Cardiologia (Academic / other)
• Locations: 1 site (São Paulo, São Paulo)
• Trial ID: NCT07259733 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 years with uncontrolled blood pressure despite treatment with 3–5 antihypertensive classes (including an ACE inhibitor/ARB, a thiazide or thiazide-like diuretic, and a calcium channel blocker) and a recent 24-hour ABPM showing ≥130/80 mmHg are ideal candidates.

Not a fit: Patients with secondary hypertension, intolerance or contraindications to ACE inhibitors, thiazide diuretics, or calcium channel blockers, those requiring indispensable beta-blockers or mineralocorticoid receptor antagonists, or with severe comorbidities are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the fixed triple pill could improve 24-hour blood pressure control while simplifying treatment and improving adherence by reducing pill burden.

How similar studies have performed: Previous studies show fixed-dose combinations improve adherence and blood pressure control, but fixed triple-pill strategies specifically for apparent resistant hypertension are less well studied.

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).

\-

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;

\-

Where this trial is running

São Paulo, São Paulo

• Instituto Dante Pazzanese de Cardiologia — São Paulo, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: Antonio G Laurinavicius, MD, PhD

Conditions Apparent Resistant Hypertension; Hypertension; High Blood Pressure; Apparent resistant hypertension; Fixed-dose combination; Triple combination therapy; Perindoprile; Indapamide