The Brazilian Cardioprotective Nutritional Program to Reduce Events and Risk Factors in Secondary Prevention for Cardiovascular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,534
- 试验地点
- 35
- 主要终点
- Composity of Major Cardiovascular Events
研究概览
简要总结
There are no studies exploring the benefits of a diet composed of typical Brazilian food in the secondary prevention of cardiovascular diseases. Randomized studies show that the Mediterranean diet is beneficial for patients with established cardiovascular disease or in risk for CVD development. Indeed, nutritional composition of the Mediterranean Diet is one of main references for dietary guidelines for treatment and prevention of CVD in Brazil and the world. However, in many countries, such as Brazil, most foods of the Mediterranean diet are not widely available, may be expensive or are not part of population eating habits. So, the prescription of the Mediterranean diet intervention for cardiovascular disease to the Brazilian population may not be feasible, leading to a low adherence. In this context, patients with established CVD have a low compliance to nutritional prescription. The BALANCE Program, considers 3 concepts: a) A dietary prescription guided by nutritional content recommendations from the Brazilian national guidelines; b) A nutritional education program based on fun, playful strategies and suggestions of affordable foods; and c) Intensive follow-up through one-on-one visits, group sessions, and phone calls. This is the first proposal to use these concepts concurrently with the objective to increase adherence of secondary prevention patients to the diet proposed by the guidelines. Therefore, The primary outcome is a composite of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, or hospitalization for unstable angina.
详细描述
The BALANCE Program will investigate the effect of the Program in reducing cardiovascular events, such as cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, hospitalization for unstable angina, or death in patients with established cardiovascular disease. Moreover the aim is to evaluate the effect of the dietary program on reducing cardiovascular risk factors, such as body mass index, waist circumference, blood pressure, total cholesterol, low density lipoprotein (LDL), triglycerides and fasting glucose. Also the objective is to compare the dietary patterns after interventions, the effect of the intervention among nutrients and energy consumption and, finally, to evaluate the BALANCE Program comprehension.
The BALANCE Program is a randomized, multicenter, national trial with allocation concealment and intention-to-treat analysis. The elegibility criteria is patients aged 45 years or more with any evidence of established cardiovascular disease to the BALANCE program or control groups. BALANCE Program is composed by 3 concepts: a) a diet that provides 50-60% of energy from carbohydrate, 10-15% from protein, 25-35% from total fat, <7% from saturated fatty acids, <10% polyunsaturated fatty acids, <20% monounsaturated fatty acids, <1% trans fats, <200 mg/day cholesterol, 20-30 g/day fiber, and <2,400 mg/day sodium; b) Nutrition education program based on ludic strategies and indication of affordable foods; c) An intense follow up by individual and group visits and phone calls. For Control group, generalized advices to follow a low fat, low energy, low sodium and low cholesterol diet are given. The primary composite outcome is the occurrence of of death (any cause), cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease or hospitalization for unstable angina. Blinded assessors will adjudicate clinical events and analysis will follow the intention-to-treat principle. Were enrolled 2534 patients in 35 sites. Enrollment was open in March 2013 and ended in March 2015 and patients will be followed up to 48 months.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any evidence of coronary artery disease (CAD) over the preceding 10 years, as defined by any of the following criteria:
- •defined by previous myocardial infarction,
- •stable or unstable angina,
- •history of atherosclerotic stenosis ≥70% of the diameter of any coronary artery on conventional or computed tomographic (CT) coronary angiography,
- •history of angioplasty, stenting, or coronary artery bypass surgery)
- •Any evidence of stroke in the preceding 10 years
- •Peripheral Arterial Disease over the preceding 10 years, as defined by any of the following criteria:
- •ankle/arm ratio <0.9 of systolic blood pressure in either leg at rest, angiography or Doppler demonstrating >70% stenosis in a cardiac artery,
- •intermittent claudication,
- •vascular surgery for atherosclerotic disease,
- •amputation due to atherosclerotic disease,
- •aortic aneurysm
排除标准
- •Refusal to provide Informed Consent Statement
- •neurocognitive or psychiatric condition that may hinder collection of reliable clinical data (defined at the trial investigator's discretion)
- •Life expectancy less than 6 months
- •Pregnancy or lactation
- •Liver failure with a history of encephalopathy or anasarca
- •Renal Failure with indication for dialysis
- •Congestive heart failure
- •Previous organ transplantation
- •Wheelchair use
- •Any restrictions to receiving an oral diet.
研究组 & 干预措施
Control Diet group
generalized advices to follow a low fat, low energy, low sodium and low cholesterol diet are given.
干预措施: Control diet (Behavioral)
BALANCE group
BALANCE Program is composed by 3 concepts: a) a diet composed of 50-60% of energy from carbohydrate, 10-15% of energy from protein; 25-35% of energy from fat (<7% saturated fatty acid; <10% polyunsaturated fatty acid; <20% monounsaturated fatty acid, <1% trans fatty acid), <200 mg/day of cholesterol, 20-30 g/day of fiber and <2400 mg/day of sodium; b) Nutrition education program based on ludic strategies and indication of affordable foods; c) An intense follow up by individual and group visits and phone calls.
干预措施: BALANCE (Behavioral)
结局指标
主要结局
Composity of Major Cardiovascular Events
时间窗: up to 48 month
The primary composite outcome will be the occurrence of any of the following cardiovascular events: cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, hospitalization for unstable angina, cardiovascular death, or death from any cause. The Clinical Endpoints Committee (CEC) will be responsible for adjudication of primary composite outcome components. All suspected events will be entered into the CEC tracking database and independently reviewed by two CEC physicians. If the two adjudicators agree, event adjudication will be considered complete. If there is disagreement, the final decision will be made by a third, independent adjudicator. It will be reported in events per person-years and crude rate per 1000 person-years.
次要结局
- LDL - cholesterol (mg/dl)(up to 48 month)
- Blood pressure (mmHg)(up to 48 month)
- waist circumference (cm)(up to 48 month)
- Triglycerides (mg/dL)(up to 48 month)
- BALANCE Program comprehension(up to 48 month)
- Total cholesterol (mg/dl)(up to 48 month)
- Fasting glucose (mg/dL)(up to 48 month)
- Body-mass index (kg/m2)(up to 48 month)
- nutrient and energy intake analysis(up to 48 month)
- dietary pattern analysis(up to 48 month)
- Cost-effectiveness analysis of diet quality (U$/DQIscore)(up to 36 month)
- isolated occurrence of cardiovascular events(up to 48 month)
- isolated cardiovascular death or death from any cause(up to 48 month)
- Cost-effectiveness analysis of clinical events (U$/events)(up to 36 month)