Actively Recruiting
Rapid Management of Resistant Hypertension in the Public Health System (Fast Control)
Led by Instituto Dante Pazzanese de Cardiologia · Updated on 2025-12-02
142
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
Sponsors
I
Instituto Dante Pazzanese de Cardiologia
Lead Sponsor
S
Servier
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Rapid Management of Resistant Hypertension in the Public Health System (Fast Control)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Recent 24-hour ambulatory blood pressure monitoring (ABPM) within 1 month showing blood pressure above 130/80 mmHg
- Office blood pressure 140/90 mmHg or higher
- Poor adherence to treatment defined as a score of 1 point or more on the Morisky Medication Adherence Scale (MMAS-4)
You will not qualify if you...
- Secondary hypertension including hyperaldosteronism, pheochromocytoma, or renovascular hypertension
- History of intolerance or adverse reactions to study medications such as ACE inhibitors, thiazide diuretics, or calcium channel blockers
- Indispensable use of beta-blockers or mineralocorticoid receptor antagonists
- Office blood pressure 220/120 mmHg or higher
- Reduced left ventricular ejection fraction below 55%
- Severe renal impairment with creatinine clearance or eGFR below 30 mL/min/1.73 m2
- Atrial fibrillation or atrial flutter
- Use of oral anticoagulants
- Significant valvular heart disease
- Body mass index 40 kg/m2 or higher
- Pregnant or breastfeeding women
- Severe psychiatric disorders
- Active malignancy with life expectancy less than 2 years
AI-Screening
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Trial Site Locations
Total: 1 location
1
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, Brazil, 04012909
Actively Recruiting
Research Team
A
Antonio G Laurinavicius, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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