Rapid Management of Resistant Hypertension in the Public Health System (Fast Control)
Strategy for Rapid Control of Apparent Resistant Arterial Hypertension in the Public Health System (FAST Control)
Instituto Dante Pazzanese de Cardiologia
142 participants
Jul 15, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria13
- 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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Interventions
Participants receive a fixed-dose tablet containing perindopril 10 mg, indapamide 2.5 mg, and amlodipine 10 mg administered once daily for 12 weeks. Randomized participants in this group discontinue their previous antihypertensive medications and replace them with the single-pill triple fixed-dose combination. Treatment adjustments may be made if required according to office blood pressure measurements
Participants continue their usual antihypertensive therapy, consisting of up to five drug classes administered as separate tablets. Medication types and doses are adjusted by the investigator as needed to achieve office blood pressure control, following standard clinical practice. Treatment modifications are permitted throughout the 12-week study period according to clinical judgment and blood pressure response.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07259733