Strategy for Rapid Control of Apparent Resistant Arterial Hypertension in the Public Health System (FAST Control)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

• \-

Locations
Other Locations
Brazil
Instituto Dante Pazzanese de Cardiologia
RECRUITING
São Paulo
Contact Information
Primary
Antonio G Laurinavicius, MD, PhD
antonio.laurinavicius@gmail.com
5511996695389
Time Frame
Start Date: 2023-07-15
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 142
Treatments
Experimental: Simplified Fixed-Dose Triple Combination
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.
Active_comparator: Usual Care Antihypertensive Regimen
Participants continue their usual antihypertensive treatment regimen, consisting of up to five drug classes administered as separate tablets, for 12 weeks, with medication adjustments performed as needed according to office blood pressure measurements.
Related Therapeutic Areas
Sponsors
Collaborators: Servier
Leads: Instituto Dante Pazzanese de Cardiologia

This content was sourced from clinicaltrials.gov