Brazilian Cardioprotective Nutritional Program Trial

Cardiovascular Diseases Clinical Trial

— BALANCE  

Official title:

The Brazilian Cardioprotective Nutritional Program to Reduce Events and Risk Factors in Secondary Prevention for Cardiovascular Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01620398
• Other study ID #: BCDT
• Status: Completed
• Phase: N/A
• Start date: March 5, 2013
• Est. completion date: December 2017

Study information

• Verified date: May 2018
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2534
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Behavioral:
• BALANCE

• Control diet
Participants will be encourage to follow a generalized diet counseling prepared by dietitians based on low fat, low energy, low sodium and low cholesterol diets. They will receive a common folder composed by lists of foods that should be preferred or avoided. For example, avoidance of ultra processed foods, preference for boiled and baked foods rather than fried foods and recommendation of having at least five meals a day. This folder is equivalent of several that are given on ambulatories or hospital of Brazilian public health.

Locations

Country	Name	City	State
Brazil	Hospital São Lucas	Aracaju	Sergipe
Brazil	Hospital Universitário FUFSE	Aracaju	Sergipe
Brazil	URCAMP	Bagé	Rio Grande Do Sul
Brazil	Hospital das Clínicas Gaspar Viana	Belém	Pará
Brazil	Hospital Universitário de Brasília	Brasília
Brazil	Hospital Universitário Alcides Carneiro	Campina Grande	Paraiba
Brazil	Hospital Universitário Maria Aparecida Pedrossian	Campo Grande	Mato Grosso Do Sul
Brazil	Hospital Universitário AESC	Canoas	Rio Grande Do Sul
Brazil	Universidade Federal do Mato Grosso	Cuiabá	Mato Grosso
Brazil	Hospital de Clínicas da Universidade Federal do Paraná	Curitiba	Paraná
Brazil	Hospital de Messejana	Fortaleza	Ceará
Brazil	Universidade de Fortaleza	Fortaleza	Ceará
Brazil	Hospital das Clínicas de Goiânia	Goiânia	Goiás
Brazil	Universidade Vale do Itajaí	Itajaí	Santa Catarina
Brazil	Universidade Federal de Alagoas	Maceió	Alagoas
Brazil	Hospital Universitário Francisca Mendes	Manaus	Amazonas
Brazil	Universidade Federal de Tocantins	Palmas	Tocantins
Brazil	BIOSERV	Passo Fundo	Rio Grande Do Sul
Brazil	Universidade Federal de Pelotas	Pelotas	Rio Grande Do Sul
Brazil	COTENUT	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul
Brazil	Instituto de Cardiologia do Rio Grande do Sul	Porto Alegre	Rio Grande Do Sul
Brazil	Pronto Socorro Cardiológico Universitário de Pernambuco	Recife	Pernambuco
Brazil	Hospital Universitario Pedro Ernesto	Rio de Janeiro
Brazil	IECAC	Rio de Janeiro	RJ
Brazil	Instituto Nacional de Cardiologia	Rio de Janeiro
Brazil	Hospital Universitário Professor Edgard Santos / ENUFBA / UFBA	Salvador	Bahia
Brazil	Hospital Universitário Ana Bezerra	Santa Cruz	Rio Grande Do Norte
Brazil	Hospital Universitário Federal Presidente Dutra	São Luiz	Maranhão
Brazil	Hospital do Coração	São Paulo
Brazil	Instituto Dante Pazzanese de Cardiologia	São Paulo
Brazil	Universidade Federal de São Paulo	São Paulo
Brazil	Associação Veranense de Assistência em Saúde (AVAES)	Veranópolis	Rio Grande Do Sul
Brazil	Universidade Federal de Viçosa	Viçosa	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Hospital do Coracao

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composity of Major Cardiovascular Events	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.	up to 48 month
Secondary	Total cholesterol (mg/dl)	For biochemical analyses blood samples will be collected and handled according to routine hospital practice. All participants will be fasted for at least 12 hours before phlebotomy. It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations.	up to 48 month
Secondary	LDL - cholesterol (mg/dl)	For biochemical analyses blood samples will be collected and handled according to routine hospital practice. It will be estinated by Friedewald formula. All participants will be fasted for at least 12 hours before phlebotomy. It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations	up to 48 month
Secondary	Fasting glucose (mg/dL)	For biochemical analyses blood samples will be collected and handled according to routine hospital practice. All participants will be fasted for at least 12 hours before phlebotomy. It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations.	up to 48 month
Secondary	Blood pressure (mmHg)	It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations	up to 48 month
Secondary	Body-mass index (kg/m2)	Compose by body weight (in kilograms) and body height (in meters), reported in kg/m².It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations.	up to 48 month
Secondary	waist circumference (cm)	It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations. The values of the circumferences will be expressed in centimeters (cm). The waist circumference should be measured through the midpoint between the lower border of the costal arch and the iliac crest in the medial axillary line.	up to 48 month
Secondary	Triglycerides (mg/dL)	For biochemical analyses blood samples will be collected and handled according to routine hospital practice. All participants will be fasted for at least 12 hours before phlebotomy.; It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations	up to 48 month
Secondary	isolated occurrence of cardiovascular events	cardiac arrest, acute myocardial infarction, stroke, myocardial revascularization, amputation for peripheral arterial disease, hospitalization for unstable angina, or isolated cardiovascular death.; 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.	up to 48 month
Secondary	isolated cardiovascular death or death from any cause	isolated 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.	up to 48 month
Secondary	nutrient and energy intake analysis	It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations.; Dietary intake data was assessed from two 24-hour recall from each visit, collected by trained interviewers. Nutrients will be present in grams/day and in % of calories and energy in Kcal.	up to 48 month
Secondary	dietary pattern analysis	a posteriori and/or a priori analysis. The dietary intake data will be obtain from two 24-hour recalls and the nutrient variability was adjusted by the Multiple Source Method (MSM). Dietary patterns were obtained by principal component analysis, and the scores were categorized into tertiles.	up to 48 month
Secondary	BALANCE Program comprehension	Each telephone monitoring will address questions about the nutritional guidelines received by the patient in order to identify the understanding of the information after the follow-up visit. The answers will be imputed in an electronic system developed for the telephone monitoring of DICA Br.; It will be analysed by chi-square and/or regression analysis.	up to 48 month
Secondary	Cost-effectiveness analysis of clinical events (U$/events)	A cost-effectiveness analysis will be performed taking into consideration the societal perspective. BALANCE diet cost and the healthcare expenditures will be estimated in both intervention and control groups among individuals who were adherent to BALANCE study protocol.; Clinical outcomes will determine the effectiveness of the BALANCE study. The expected clinical outcomes are death, cardiac arrest, myocardial infarction, stroke, myocardial revascularization, amputation, or angina. Differences between the cost-effectiveness rates fwill determine the cost-effectiveness analysis of clinical events. External validity will be performed using sensibility analyses.	up to 36 month
Secondary	Cost-effectiveness analysis of diet quality (U$/DQIscore)	A cost-effectiveness analysis will be performed taking into consideration the societal perspective. BALANCE diet cost and the healthcare expenditures will be estimated in both intervention and control groups among individuals who were adherent to BALANCE study protocol.; Diet quality will be obtained by diet quality index (DQI) and will determine the effectiveness of the BALANCE study.; Differences between the cost-effectiveness rates will determine the Cost-effectiveness analysis of diet quality External validity will be performed using sensibility analyses.	up to 36 month