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

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…

ClinicalTrials.gov IDNCT07259733

PhaseNA

Enrollment142

SponsorInstituto Dante Pazzanese de Cardiologia

Age18 Years

SexALL

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Conditions studied

Apparent Resistant Hypertension, Hypertension, High Blood Pressure

About this study

Interventions

Drug: Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine) — 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
Drug: Usual Care Antihypertensive Regimen — 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.

Primary outcomes

Rate of 24-hour Blood Pressure Control Measured by ABPM at 12 weeks (12 weeks)
Rate of 24-hour Blood Pressure Control Measured by Ambulatory Blood Pressure Monitoring (ABPM) at 12 weeks (12 weeks)

Eligibility information

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; \-

Study locations

Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo 04012909 Brazil

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.