Matão Controlling Hypertension (MatCH Study): Rationale and Design. Project to Reduce Incidence of Arterial Hypertension in City of Matão, Brazil.
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 15,000
- 主要终点
- Number of hypertensive subjects with BP controlled during follow-up
研究概览
简要总结
Background Hypertension is the main risk factor for most cardiovascular diseases. Blood pressure (BP) control has been shown to reduce the incidence of stroke, myocardial infarction, renal diseases and heart failure. Although BP lowering is effective, few population programs can achieve BP control. A coordinated and organized system from the Brazilian Ministry of Healthy involving Family Health Strategy (FHS), a program for the prevention of chronic disease, and the Popular Pharmacy Program (PPP), which subsidizes medications for the population, could allow an earlier identification and better BP control. Matão Controlling Hypertension (MatCH) is a community-based population project that aims to apply an organized, integrated and coordinated program in the city of Matão, Brazil, involving FSH and PPP in order to actively search, treat and follow-up hypertensive subjects.
Method This is a population community-based, prospective, interventional, follow-up study where all subjects aged ≥ 40 years assisted by the FHS program in Matão will have BP assessed monthly by trained Community Health Agents (CHA) during a domiciliary visit. Identified hypertensive subjects will be referred to FHS physicians for nonpharmacological and pharmacological treatment. Most of the hypertensive drugs used will be available thought the PPP. Prevalence of hypertension, awareness, demographics and risk factors will be correlated with BP control. The population study is expected to involve approximately 15,000 subjects. The study period will be four years.
Discussion Considering that hypertension is asymptomatic in most cases, to reduce the population burden of BP-related deaths and diseases it is essential to detect and treat early all hypertensive patients. If BP control be achieved on a large scale, this program can be applied to other populations from developing countries.
详细描述
Hypertension is the main risk factor associated with the global burden of disease and mortality.
Brazil, a middle-income country and the largest in Latin America, has a prevalence of hypertension of about 35% (Ribeiro AL et al, 2016), with no significant difference between genders.
A decrease in cardiovascular disease mortality has been observed. This phenomenon could be attributed to some public healthy preventive programs such as the Family Healthy Strategy (FHS) (Macinko J et al, 2015) and the Popular Pharmacy Program (PPP) (Emmerick I et al, 2015), both supported by the Brazilian Ministry of Healthy. FHS is focused on a community-based approach to providing primary health care. Physicians, nurses, and community health agents (CHA) visit residents in their homes to prevent complications and to take care of chronic diseases.
The purpose of the Matão Controlling Hypertension (MatCH) project is to apply an organized, integrated and coordinated program of all health services in Matão, mainly involving FSH and PPP, for an earlier identification of hypertensive individuals, followed by treatment and follow-up in order to control their BP.
Objective
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All consented subjects aged ≥ 40 years belonging to Family Strategy Health program and residing in Matão.
排除标准
- •Patients younger than 40 years.
- •Subjects not belonging to Family Strategy Health program in Matão.
研究组 & 干预措施
Hypertension group
Hypertensive patients will be counseled to initiate life style changes as weight loss, salt reduction, exercise, reduced alcohol consumption, smoking cessation and fresh fruits and vegetables in their diets. Drug treatment will be started for subjects that are not responding to nonpharmacological treatment. The anti-hypertensive medications will be Captopril 25Mg, Hydrochlorothiazide 25Mg Oral Tablet, atenolol and Losartan potassium 50 mg. All of these anti-hypertensive drugs are available in the PPP. If BP control is not yet obtained, other antihypertensive drugs will be requested: clonidine, spironolactone, hydralazine and amlodipine.
干预措施: Captopril 25Mg, Hydrochlorothiazide 25Mg Oral Tablet, (Drug)
Hypertension group
Hypertensive patients will be counseled to initiate life style changes as weight loss, salt reduction, exercise, reduced alcohol consumption, smoking cessation and fresh fruits and vegetables in their diets. Drug treatment will be started for subjects that are not responding to nonpharmacological treatment. The anti-hypertensive medications will be Captopril 25Mg, Hydrochlorothiazide 25Mg Oral Tablet, atenolol and Losartan potassium 50 mg. All of these anti-hypertensive drugs are available in the PPP. If BP control is not yet obtained, other antihypertensive drugs will be requested: clonidine, spironolactone, hydralazine and amlodipine.
干预措施: Atenolol (Drug)
Hypertension group
Hypertensive patients will be counseled to initiate life style changes as weight loss, salt reduction, exercise, reduced alcohol consumption, smoking cessation and fresh fruits and vegetables in their diets. Drug treatment will be started for subjects that are not responding to nonpharmacological treatment. The anti-hypertensive medications will be Captopril 25Mg, Hydrochlorothiazide 25Mg Oral Tablet, atenolol and Losartan potassium 50 mg. All of these anti-hypertensive drugs are available in the PPP. If BP control is not yet obtained, other antihypertensive drugs will be requested: clonidine, spironolactone, hydralazine and amlodipine.
干预措施: Losartan potassium 50mg (Drug)
Hypertension group
Hypertensive patients will be counseled to initiate life style changes as weight loss, salt reduction, exercise, reduced alcohol consumption, smoking cessation and fresh fruits and vegetables in their diets. Drug treatment will be started for subjects that are not responding to nonpharmacological treatment. The anti-hypertensive medications will be Captopril 25Mg, Hydrochlorothiazide 25Mg Oral Tablet, atenolol and Losartan potassium 50 mg. All of these anti-hypertensive drugs are available in the PPP. If BP control is not yet obtained, other antihypertensive drugs will be requested: clonidine, spironolactone, hydralazine and amlodipine.
干预措施: Clonidine (Drug)
结局指标
主要结局
Number of hypertensive subjects with BP controlled during follow-up
时间窗: Through study completion, an average of 2 years
Controlled BP will be defined as systolic blood pressure ≤ 139 mmHg and diastolic blood pressure ≤ 89 mmHg.
次要结局
- Correlation of BP control with demographics(Through study completion, an average of 3 years)
- Correlation of BP control with risk factors(Through study completion, an average of 3 years)
- Correlation of BP end organ disease(Through study completion, an average of 3 years.)