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New treatment option for Apparent Resistant Hypertension
Official title Rapid Management of Resistant Hypertension in the Public Health System (Fast Control)
ClinicalTrials.gov ID: NCT07259733
What this study is testing
What is Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine)?
Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for apparent resistant hypertension.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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 likely can't join if
- Secondary hypertension (including hyperaldosteronism, pheochromocytoma, or renovascular hypertension);
- History of intolerance or adverse reactions to study medications, such as ACE inhibitors (cough or angioedema), thiazide or thiazide-like diuretics...
- 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);
See the full eligibility criteria
- 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 (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).
- Secondary hypertension (including hyperaldosteronism, pheochromocytoma, or renovascular hypertension);
- 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...
- 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;
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.