ABSTRACT
This article reports the rationale for the Brazilian Cardioprotective Nutritional Program (BALANCE Program) Trial. This pragmatic, multicenter, nationwide, randomized, concealed, controlled trial was designed to investigate the effects of the BALANCE Program in reducing cardiovascular events. The BALANCE Program consists of a prescribed diet guided by nutritional content recommendations from Brazilian national guidelines using a unique nutritional education strategy, which includes suggestions of affordable foods. In addition, the Program focuses on intensive follow-up through one-on-one visits, group sessions, and phone calls. In this trial, participants 45 years or older with any evidence of established cardiovascular disease will be randomized to the BALANCE or control groups. Those in the BALANCE group will receive the afore mentioned program interventions, while controls will be given generic advice on how to follow a low-fat, low-energy, low-sodium, and low-cholesterol diet, with a view to achieving Brazilian nutritional guideline recommendations. 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. A total of 2468 patients will be enrolled in 34 sites and followed up for up to 48 months. If the BALANCE Program is found to decrease cardiovascular events and reduce risk factors, this may represent an advance in the care of patients with cardiovascular disease.
Subject(s)
Cardiovascular Diseases/prevention & control , Diet/methods , National Health Programs/standards , Nutrition Assessment , Secondary Prevention/methods , Brazil/epidemiology , Cardiovascular Diseases/epidemiology , Feeding Behavior , Humans , Incidence , Survival Rate/trendsABSTRACT
BACKGROUND: Risk factors for cardiovascular mortality have barely been investigated in very elderly persons and there may be differences compared with younger individuals. METHODS: This is a cohort study of all inhabitants over 80 years of age in the city of Veranópolis, Brazil. The association of demographic, anthropometric, physical, and medical characteristics with mortality by any cause and by cardiovascular disease (CVD) was investigated by means of Cox regression models. RESULTS: The mean age of the participants was 83.6 ± 3.3 years. Vital status and cause of death was ascertained in 96.9% of the participants after a mean follow-up of 8.7 ± 3.8 years. Systolic and diastolic blood pressure showed a U-shape relationship with cardiovascular and total mortality. Blood pressure lower than 140/90 mmHg was associated with a higher risk for cardiovascular mortality (HR 4.76, 95% CI 1.56-14.28, p = 0.006). Duration of sleep was inversely associated with the risk of cardiovascular death (HR 0.83, 95% CI 0.73-0.95, p = 0.007), while apoA-I was inversely associated only with the risk of all-cause mortality (HR 0.99, 95% CI 0.98-1.00, p = 0.041). Anthropometric indexes, smoking, cholesterol, LDL-cholesterol, HDL-cholesterol, and other traditional risk factors were not associated with cardiovascular mortality. CONCLUSION: Many traditional risk factors are not associated with cardiovascular mortality in the very elderly. Longer sleep duration is associated with lower cardiovascular mortality of very elderly individuals, while low blood pressure identifies very elderly individuals at higher risk of dying from cardiovascular causes.
