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

NCT07259733 | Recruiting DMC

• 1 other identifier: 56042422900005462
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Apparent Resistant Hypertension; Hypertension; High Blood Pressure

Keywords

Apparent resistant hypertension; Fixed-dose combination; Triple combination therapy; Perindoprile; Indapamide; Amlodipine; Clinical Trial; Brazil

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  12 weeks

Study Arms (2)

Simplified Fixed-Dose Triple Combination

EXPERIMENTAL

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.

Drug: Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine)

Usual Care Antihypertensive Regimen

ACTIVE COMPARATOR

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.

Drug: Usual Care Antihypertensive Regimen

Interventions

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

Simplified Fixed-Dose Triple Combination

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.

Usual Care Antihypertensive Regimen

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• History of intolerance or adverse reactions to study medications, such as ACE inhibitors (cough or angioedema), thiazide or thiazide-like diuretics (electrolyte disturbances), or calcium channel blockers (significant ankle edema or headache);
• Indispensable use of beta-blockers or mineralocorticoid receptor antagonists;
• Office blood pressure ≥ 220 × 120 mmHg;
• Reduced left ventricular ejection fraction (LVEF \< 55%);
• Severe renal impairment (creatinine clearance \< 30 mL/min or eGFR \< 30 mL/min/1.73 m²);
• Atrial fibrillation or atrial flutter;
• Use of oral anticoagulants;
• Significant valvular heart disease;
• Body mass index (BMI) ≥ 40 kg/m²;
• Pregnant or breastfeeding women;
• Severe psychiatric disorders;
• Active malignancy with life expectancy \< 2 years;

Sponsors & Collaborators

• Instituto Dante Pazzanese de Cardiologia: lead
• Servier: collaborator

Study Sites (1)

Instituto Dante Pazzanese de Cardiologia

São Paulo, São Paulo, 04012909, Brazil

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Indapamide; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Antonio G Laurinavicius, MD, PhD

CONTACT

5511996695389; antonio.laurinavicius@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Model Details: Participants are randomized in a 1:1 ratio to receive either a simplified fixed-dose triple combination (perindopril 10 mg/indapamide 2.5 mg/amlodipine 10 mg once daily) or usual care with their current individualized antihypertensive regimen (up to five drug classes). Each group follows its assigned treatment throughout the 12-week study period.

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: July 15, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: December, 2026
• Access Criteria: Participants data and supporting documents will be available to qualified researchers for scientific purposes upon reasonable request. Access will be granted after approval of a written proposal and execution of a data use agreement. Data will be shared eletronically through secure institutional channels.

Locations

BR (1)