Strategy for Rapid Control of Apparent Resistant Arterial Hypertension in the Public Health System (FAST Control)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Rate of 24-hour Blood Pressure Control Measured by ABPM at 12 weeks
研究概览
简要总结
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.
详细描述
Resistant hypertension remains a major clinical challenge, frequently resulting from therapeutic inertia, poor adherence, and the complexity of multi-drug regimens. Simplified treatment strategies, such as fixed-dose combinations, have been proposed to improve adherence and blood pressure control.
The FAST Control study is a single-center, open-label, randomized (1:1), parallel-group clinical trial designed to compare the efficacy of a simplified treatment strategy versus usual care in patients with apparent resistant hypertension (aRHTN). The simplified treatment consists of a fixed triple combination of perindopril 10 mg, indapamide 2.5 mg, and amlodipine 10 mg once daily, while the usual care group maintains their current regimen with up to five antihypertensive drug classes administered as separate tablets.
Eligible participants are adults aged 18 to 75 years, followed at the Hypertension Section of the Instituto Dante Pazzanese de Cardiologia (São Paulo, Brazil), presenting with uncontrolled blood pressure despite treatment with 3-5 drug classes (including a renin-angiotensin system blocker, a thiazide or thiazide-like diuretic, and a long-acting calcium channel blocker). Apparent resistant hypertension is confirmed by 24-hour ambulatory blood pressure monitoring (ABPM) showing a mean BP ≥130/80 mmHg. Participants with secondary hypertension, severe comorbidities, or contraindications to the study medications are excluded.
The primary objective is to compare the rate of 24-hour blood pressure control as measured by ABPM at 12 weeks between the simplified treatment and usual care groups. Secondary objectives include evaluating the difference in absolute reduction of 24-hour blood pressure (BP), as measured by ABP between the two groups; comparing the office blood pressure control rate after 12 weeks between the groups; assessing the difference in absolute reduction of office blood pressure between the groups; and comparing the number of antihypertensive drug classes and the total number of pills used between the groups throughout the study.
This study was approved by the Research Ethics Committee of the Instituto Dante Pazzanese de Cardiologia (CAAE [56042422900005462]) and registered retrospectively, as patient enrollment began on July 15, 2023.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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;
研究组 & 干预措施
Simplified Fixed-Dose Triple Combination
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.
干预措施: Triple Fixed-Dose Combination (Perindoprile/Indapamide/Amlodipine) (Drug)
Usual Care Antihypertensive Regimen
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.
干预措施: Usual Care Antihypertensive Regimen (Drug)
结局指标
主要结局
Rate of 24-hour Blood Pressure Control Measured by ABPM at 12 weeks
时间窗: 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.
Rate of 24-hour Blood Pressure Control Measured by Ambulatory Blood Pressure Monitoring (ABPM) at 12 weeks
时间窗: 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.
次要结局
未报告次要终点
研究者
Fabrizio Urbinati Maroja
MD, MSc
Instituto Dante Pazzanese de Cardiologia