NCT07259733 Rapid Management of Resistant Hypertension in the Public Health System (Fast Control)
| NCT ID | NCT07259733 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Instituto Dante Pazzanese de Cardiologia |
| Condition | Apparent Resistant Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 142 participants |
| Start Date | 2023-07-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 142 participants in total. It began in 2023-07-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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; \-
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07259733 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Apparent Resistant Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07259733 currently recruiting?
Yes, NCT07259733 is actively recruiting participants. Contact the research team at antonio.laurinavicius@gmail.com for enrollment information.
Where is the NCT07259733 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT07259733 clinical trial?
NCT07259733 is sponsored by Instituto Dante Pazzanese de Cardiologia. The trial plans to enroll 142 participants.