Rapid Management of Resistant Hypertension in the Public Health System (Fast Control)

ConditionsApparent Resistant Hypertension Hypertension High Blood Pressure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorInstituto Dante Pazzanese de Cardiologia

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine)
Drug
Participants receive a fixed-dose tablet containing perindopril 10 mg, indapamide 2.5 mg, and amlodipine 10 mg administered once daily for 12 weeks. 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
Usual Care Antihypertensive Regimen
Drug
Participants continue their usual antihypertensive therapy, consisting of up to five drug classes administered as separate tablets. Medication types and doses are adjusted by the investigator as needed to achieve office blood pressure control, following standard clinical practice. Treatment modifications are permitted throughout the 12-week study period according to clinical judgment and blood pressure response.

Treatment groups

142 Participants

are divided into 2 treatment groups

Group A: Simplified Fixed-Dose Triple CombinationExperimental treatment 1 intervention

Group B: Usual Care Antihypertensive RegimenActive comparator 1 intervention

Trial outcomes

Primary outcomes

Rate of 24-hour Blood Pressure Control Measured by ABPM at 12 weeks

Proportion of participants achieving 24-hour mean blood pressure \<130/80 mmHg, as measured by ambulatory blood pressure monitoring (ABPM), after 12 weeks of treatment.

Time frame

12 weeks

Rate of 24-hour Blood Pressure Control Measured by Ambulatory Blood Pressure Monitoring (ABPM) at 12 weeks

Proportion of participants achieving 24-hour mean blood pressure \<130/80 mmHg, as measured by ambulatory blood pressure monitoring (ABPM), after 12 weeks of treatment.

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto Dante Pazzanese de Cardiologia

Lead sponsor

Servier

Collaborator

Source ClinicalTrials.gov

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