Rapid Management of Resistant Hypertension in the Public Health System (Fast Control)
Recruiting · NCT07259733 · Interventional (participants receive a specific treatment) · Lead sponsor: Instituto Dante Pazzanese de Cardiologia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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);
- ffice 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;
- ffice 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 it is running
1 location listed.
- Instituto Dante Pazzanese de Cardiologia - São Paulo, São Paulo, Brazil