RecruitingNot ApplicableNCT07259733

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

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


Sponsor

Instituto Dante Pazzanese de Cardiologia

Enrollment

142 participants

Start Date

Jul 15, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a structured, rapid treatment program can better control blood pressure in people with resistant hypertension — high blood pressure that stays high despite being on three or more medications. **You may be eligible if...** - You are between 18 and 75 years old - You are currently taking 3 to 5 blood pressure medications, including at least one ACE inhibitor or ARB, a diuretic (water pill), and a calcium channel blocker - A recent 24-hour blood pressure monitor confirms your blood pressure is still above target - Your office blood pressure reading is at or above 140/90 mmHg **You may NOT be eligible if...** - You have secondary causes of high blood pressure (such as kidney artery narrowing or hormonal tumors) that have not been treated - You have severe kidney disease or other serious conditions - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTriple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine)

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

DRUGUsual Care Antihypertensive Regimen

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.


Locations(1)

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, Brazil

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NCT07259733


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