Clinical trial NCT01620398: Brazilian Cardioprotective Nutritional Program Trial
Official title: The Brazilian Cardioprotective Nutritional Program to Reduce Events and Risk Factors in Secondary Prevention for Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: cardiovascular diseases
secondary prevention
diet
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
First posted: 2012-06-15
Enrollment: 2534
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composity of Major Cardiovascular Events
timeFrame: up to 48 month
Secondary outcomes:
measure: Total cholesterol (mg/dl)
timeFrame: up to 48 month
measure: LDL - cholesterol (mg/dl)
timeFrame: up to 48 month
measure: Fasting glucose (mg/dL)
timeFrame: up to 48 month
measure: Blood pressure (mmHg)
timeFrame: up to 48 month
measure: Body-mass index (kg/m2)
timeFrame: up to 48 month
measure: waist circumference (cm)
timeFrame: up to 48 month
measure: Triglycerides (mg/dL)
timeFrame: up to 48 month
measure: isolated occurrence of cardiovascular events
timeFrame: up to 48 month
measure: isolated cardiovascular death or death from any cause
timeFrame: up to 48 month
measure: nutrient and energy intake analysis
timeFrame: up to 48 month
measure: dietary pattern analysis
timeFrame: up to 48 month
measure: BALANCE Program comprehension
timeFrame: up to 48 month
measure: Cost-effectiveness analysis of clinical events (U$/events)
timeFrame: up to 36 month
measure: Cost-effectiveness analysis of diet quality (U$/DQIscore)
timeFrame: up to 36 month
Other outcomes:
Locations:
city: Maceió
country: Brazil
facility: Universidade Federal de Alagoas
state: Alagoas
city: Manaus
country: Brazil
facility: Hospital Universitário Francisca Mendes
state: Amazonas
city: Salvador
country: Brazil
facility: Hospital Universitário Professor Edgard Santos / ENUFBA / UFBA
state: Bahia
city: Fortaleza
country: Brazil
facility: Hospital de Messejana
state: Ceará
city: Fortaleza
country: Brazil
facility: Universidade de Fortaleza
state: Ceará
city: Goiânia
country: Brazil
facility: Hospital das Clínicas de Goiânia
state: Goiás
city: São Luiz
country: Brazil
facility: Hospital Universitário Federal Presidente Dutra
state: Maranhão
city: Campo Grande
country: Brazil
facility: Hospital Universitário Maria Aparecida Pedrossian
state: Mato Grosso Do Sul
city: Cuiabá
country: Brazil
facility: Universidade Federal do Mato Grosso
state: Mato Grosso
city: Viçosa
country: Brazil
facility: Universidade Federal de Viçosa
state: Minas Gerais
city: Campina Grande
country: Brazil
facility: Hospital Universitário Alcides Carneiro
state: Paraiba
city: Curitiba
country: Brazil
facility: Hospital de Clínicas da Universidade Federal do Paraná
state: Paraná
city: Belém
country: Brazil
facility: Hospital das Clínicas Gaspar Viana
state: Pará
city: Recife
country: Brazil
facility: Pronto Socorro Cardiológico Universitário de Pernambuco
state: Pernambuco
city: Santa Cruz
country: Brazil
facility: Hospital Universitário Ana Bezerra
state: Rio Grande Do Norte
city: Bagé
country: Brazil
facility: URCAMP
state: Rio Grande Do Sul
city: Canoas
country: Brazil
facility: Hospital Universitário AESC
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: BIOSERV
state: Rio Grande Do Sul
city: Pelotas
country: Brazil
facility: Universidade Federal de Pelotas
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: COTENUT
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia do Rio Grande do Sul
state: Rio Grande Do Sul
city: Veranópolis
country: Brazil
facility: Associação Veranense de Assistência em Saúde (AVAES)
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: IECAC
state: RJ
city: Itajaí
country: Brazil
facility: Universidade Vale do Itajaí
state: Santa Catarina
city: Aracaju
country: Brazil
facility: Hospital São Lucas
state: Sergipe
city: Aracaju
country: Brazil
facility: Hospital Universitário FUFSE
state: Sergipe
city: Palmas
country: Brazil
facility: Universidade Federal de Tocantins
state: Tocantins
city: Brasília
country: Brazil
facility: Hospital Universitário de Brasília
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Pedro Ernesto
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Cardiologia
city: São Paulo
country: Brazil
facility: Hospital do Coração
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
city: São Paulo
country: Brazil
facility: Universidade Federal de São Paulo
Study officials:
affiliation: Hospital do Coração
name: Bernardete Berwanger, NC, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital do Coração
name: Otávio Berwanger, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital do Coração
name: Rafael M Soares, NC, MSc
role: STUDY_CHAIR
affiliation: Hospital do Coração
name: Rosana P Costa, NC, MSc
role: STUDY_CHAIR
affiliation: Hospital do Coração
name: Maria B Ross-Fernandes, NC, MSc
role: STUDY_CHAIR
affiliation: Hopsital do Coração
name: Enilda S Lara, NC, PhD
role: STUDY_CHAIR
affiliation: Hospital do Coração
name: Camila R Torreglosa, NC, MSc
role: STUDY_CHAIR
affiliation: Hospital do Coração
name: Ângela C Bersch-Ferreira, NC, MSc
role: STUDY_CHAIR
affiliation: Hospital do Coração
name: Jacqueline T da Silva, NC
role: STUDY_CHAIR
affiliation: Hospital do Coração
name: Andrea P Galante, NC, PhD
role: STUDY_CHAIR
References:
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citation: de Brito Goncalves Nascimento L, Sahade V, Weber B, Pinheiro JMF, Dias LPP, Figueiredo Neto JA, Carlos Sobral Sousa A, Pinho CPS, Luna AB, Vasconcelos SML, Dantas CF, Penafort AM, Carlos DMO, Daltro C. Diabetic Patients with Cardiovascular Disease Show More Metabolic Syndrome than Nondiabetic Patients: Multicentric Study in the Northeast of Brazil. Metab Syndr Relat Disord. 2021 May;19(4):233-239. doi: 10.1089/met.2020.0064. Epub 2021 Feb 1.
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citation: da Silva A, Caldas APS, Hermsdorff HHM, Bersch-Ferreira AC, Torreglosa CR, Weber B, Bressan J. Triglyceride-glucose index is associated with symptomatic coronary artery disease in patients in secondary care. Cardiovasc Diabetol. 2019 Jul 11;18(1):89. doi: 10.1186/s12933-019-0893-2.
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