No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
142 (estimated)
Sponsor
Instituto Dante Pazzanese de Cardiologia · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 75 with high blood pressure that is hard to treat. Participants will compare a new simpler medication strategy to usual care over 12 weeks.
Are You a Good Fit for This Trial?
Rules you outSevere renal impairmentAtrial fibrillationSevere psychiatric disordersActive malignancy
You may be able to join if
I am between 18 and 75 years old.
I have high blood pressure that is difficult to control.
I have been treated with 3 to 5 different blood pressure medications.
My recent blood pressure monitoring showed values above target.
My office blood pressure is at least 140/90 mmHg.
I have poor adherence to my current treatment.
You may not be able to join if
I have secondary hypertension.
I have had serious side effects from blood pressure medications.
I need to take beta-blockers or mineralocorticoid receptor antagonists.
My office blood pressure is 220/120 mmHg or higher.
I have a reduced left ventricular ejection fraction.
I have severe kidney problems.
I have atrial fibrillation or atrial flutter.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 pri…
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.
Trial Locations
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Eligibility Criteria
Inclusion 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 …
Inclusion 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).
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Exclusion Criteria: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 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;
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