Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07259733

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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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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