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Cardiovascular DiseasesBALANCENCT01620398

Brazilian Cardioprotective Nutritional Program Trial

A study testing BALANCE in people with Cardiovascular Diseases, run by Hospital do Coracao at 35 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Cardiovascular Diseases
What is being tested?
BALANCE
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,534 participants
Where
35 sitesBrazil
Study dates
5 Mar 2013to Dec 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • Congestive heart failure
  • Previous organ transplantation
  • Wheelchair use
  • Any restrictions to receiving an oral diet.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

Brazil35 sites

  • Hospital São Lucas

    Aracaju, Sergipe

  • Hospital Universitário FUFSE

    Aracaju, Sergipe

  • URCAMP

    Bagé, Rio Grande do Sul

  • Hospital das Clínicas Gaspar Viana

    Belém, Pará

  • Hospital Universitário de Brasília

    Brasília

  • Hospital Universitário Alcides Carneiro

    Campina Grande, Paraíba

  • Hospital Universitário Maria Aparecida Pedrossian

    Campo Grande, Mato Grosso do Sul

  • Hospital Universitário AESC

    Canoas, Rio Grande do Sul, 90630000

  • Universidade Federal do Mato Grosso

    Cuiabá, Mato Grosso

  • Hospital de Clínicas da Universidade Federal do Paraná

    Curitiba, Paraná

  • Hospital de Messejana

    Fortaleza, Ceará

  • Universidade de Fortaleza

    Fortaleza, Ceará

  • Hospital das Clínicas de Goiânia

    Goiânia, Goiás, 90630000

  • Universidade Vale do Itajaí

    Itajaí, Santa Catarina

  • Universidade Federal de Alagoas

    Maceió, Alagoas

  • Hospital Universitário Francisca Mendes

    Manaus, Amazonas

  • Universidade Federal de Tocantins

    Palmas, Tocantins

  • BIOSERV

    Passo Fundo, Rio Grande do Sul, 90630000

  • Universidade Federal de Pelotas

    Pelotas, Rio Grande do Sul

  • COTENUT

    Porto Alegre, Rio Grande do Sul, 90630000

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90630000

  • Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90630000

  • Instituto de Cardiologia do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul

  • Pronto Socorro Cardiológico Universitário de Pernambuco

    Recife, Pernambuco

  • IECAC

    Rio de Janeiro, Rio de Janeiro

  • Hospital Universitario Pedro Ernesto

    Rio de Janeiro

  • Instituto Nacional de Cardiologia

    Rio de Janeiro

  • Hospital Universitário Professor Edgard Santos / ENUFBA / UFBA

    Salvador, Estado de Bahia

  • Hospital Universitário Ana Bezerra

    Santa Cruz, Rio Grande do Norte

  • Hospital Universitário Federal Presidente Dutra

    São Luiz, Maranhão

  • Hospital do Coração

    São Paulo

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo

  • Universidade Federal de São Paulo

    São Paulo

  • Associação Veranense de Assistência em Saúde (AVAES)

    Veranópolis, Rio Grande do Sul, 90630000

  • Universidade Federal de Viçosa

    Viçosa, Minas Gerais

Other trials in Brazil

About this study

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

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.

Read the 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.

Being tested
BALANCE, Control diet
Keywords
cardiovascular diseases, secondary prevention, diet
Medical subject headings
Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BALANCEBehavioural

    Also called DICA Br;, PABC;

  • Control dietBehavioural

    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.

Study groups in NCT01620398
Study groupRoleWhat they receive
BALANCE groupExperimentalBALANCE 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.
Receives: Behavioral: BALANCE
Control Diet groupActive comparatorgeneralized advices to follow a low fat, low energy, low sodium and low cholesterol diet are given.
Receives: Behavioral: Control diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 48 month

Secondary outcomes (14)

  1. 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.

    Measured: up to 48 month

  2. 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

    Measured: up to 48 month

  3. 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.

    Measured: up to 48 month

  4. Blood pressure (mmHg)

    It will be analyzed over time by repeated-measures analysis of variance using a mixed model or generalized estimating equations

    Measured: up to 48 month

  5. 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.

    Measured: up to 48 month

  6. 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.

    Measured: up to 48 month

  7. 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

    Measured: up to 48 month

  8. 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.

    Measured: up to 48 month

  9. 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.

    Measured: up to 48 month

  10. 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.

    Measured: up to 48 month

  11. 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.

    Measured: up to 48 month

  12. 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.

    Measured: up to 48 month

  13. 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.

    Measured: up to 36 month

  14. 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.

    Measured: up to 36 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2012 (estimated)
  2. Study start5 Mar 2013
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2,534 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01620398
Sponsor's protocol ID
BCDT
Acronym
BALANCE
Status last verified
May 2018
First submitted
13 Jun 2012
Last updated
29 May 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bersch-Ferreira AC, Santos RHN, Rogero MM, Machado RHV, Bressan J, Moreira ASB, Amaral CK, Marcadenti A. The role of genetic variation in apolipoprotein response to diet among Brazilians with cardiovascular disease. Eur J Clin Nutr. 2026 Aug 5. doi: 10.1038/s41430-026-01804-4. Online ahead of print.

    PubMed 42557382

  • Almeida AP, Lopes LJ, Bersch-Ferreira AC, Torreglosa CR, Marcadenti A, Weber B, Bressan J, Hermsdorff HHM. Insulin resistance mediate the association between leucine intake, dietary glycemic index, and type 2 diabetes in secondary cardiovascular prevention: path analysis from Brazilian cardioprotective nutritional (BALANCE) program. Eur J Nutr. 2025 Mar 29;64(3):140. doi: 10.1007/s00394-025-03653-6.

    PubMed 40156624

  • Bersch-Ferreira AC, Hall WL, Santos RHN, Torreglosa CR, Sampaio G, Tereza da Silva J, Alves R, Ross MB, Gehringer MO, Kovacs C, Marcadenti A, Magnoni D, Weber B, Rogero MM. The effect of the a regional cardioprotective nutritional program on inflammatory biomarkers and metabolic risk factors in secondary prevention for cardiovascular disease, a randomised trial. Clin Nutr. 2021 Jun;40(6):3828-3835. doi: 10.1016/j.clnu.2021.04.035. Epub 2021 Apr 28.

    PubMed 34130029

  • 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.

    PubMed 33523760

  • Alves da Silva R, Bersch-Ferreira AC, Gehringer MO, Ross-Fernandes MB, Kovacs do Amaral C, Lin Wang HT, Lima PH, de Lima PA, Franca JI, Weber B, Magnoni CD, Rogero MM. Effect of qualitative and quantitative nutritional plan on gene expression in obese patients in secondary prevention for cardiovascular disease. Clin Nutr ESPEN. 2021 Feb;41:351-359. doi: 10.1016/j.clnesp.2020.11.002. Epub 2020 Nov 26.

    PubMed 33487289

  • Weber B, Bersch-Ferreira AC, Torreglosa CR, Marcadenti A, Lara ES, da Silva JT, Costa RP, Santos RHN, Berwanger O, Bosquetti R, Pagano R, Mota LGS, de Oliveira JD, Soares RM, Galante AP, da Silva SA, Zampieri FG, Kovacs C, Amparo FC, Moreira P, da Silva RA, Dos Santos KG, Monteiro AS, Paiva CCJ, Magnoni CD, Moreira ASB, Pecanha DO, Missias KCS, de Paula LS, Marotto D, Souza P, Martins PRT, Dos Santos EM, Santos MR, Silva LP, Torres RS, Barbosa SNAA, de Pinho PM, de Araujo SHA, Verissimo AOL, Guterres AS, Cardoso AFR, Palmeira MM, de Ataide BRB, Costa LPS, Marinho HA, de Araujo CBP, Carvalho HMS, Maquine RO, Caiado AC, de Matos CH, Barretta C, Specht CM, Onofrei M, Bertacco RTA, Borges LR, Bertoldi EG, Longo A, Ribas BLP, Dobke F, Pretto ADB, Bachettini NP, Gastaud A, Necchi R, Souza GC, Zuchinali P, Fracasso BM, Bobadra S, Sangali TD, Salamoni J, Garlini LM, Shirmann GS, de Los Santos MLP, Bortonili VMS, Dos Santos CP, Braganca GCM, Ambrozio CL, E Lima SB, Schiavini J, Napparo AS, Boemo JL, Nagano FEZ, Modanese PVG, Cunha NM, Frehner C, da Silva LF, Formentini FS, Ramos MEM, Ramos SS, Lucas MCS, Machado BG, Ruschel KB, Beiersdorf JR, Nunes CE, Rech RL, Damiani M, Berbigier M, Poloni S, Vian I, Russo DS, Rodrigues JA, de Moraes MAP, da Costa LM, Boklis M, El Kik RM, Adorne EF, Teixeira JM, Trescastro EP, Chiesa FL, Telles CT, Pellegrini LA, Reis LF, Cardoso RGM, Closs VE, Feres NH, da Silva NF, Silva NE, Dutra ES, Ito MK, Lima MEP, Carvalho APPF, Taboada MIS, Machado MMA, David MM, Junior DGS, Dourado C, Fagundes VCFO, Uehara RM, Sasso S, Vieira JSO, de Oliveira BAS, Pereira JL, Rodrigues IG, Pinho CPS, Sousa ACS, Almeida AS, de Jesus MT, da Silva GB, Alves LVS, Nascimento VOG, Vieira SA, Coura AGL, Dantas CF, Leda NMFS, Medeiros AL, Andrade ACL, Pinheiro JMF, de Lima LRM, Sabino LS, de Souza CVS, Vasconcelos SML, Costa FA, Ferreira RC, Cardoso IB, Navarro LNP, Ferreira RB, Junior AES, Silva MBG, Almeida KMM, Penafort AM, de Queiros APO, Farias GMN, Carlos DMO, Cordeiro CGNC, Vasconcelos VB, de Araujo EMVMC, Sahade V, Ribeiro CSA, Araujo GA, Goncalves LB, Teixeira CS, Silva LMAJ, da Costa LB, Souza TS, de Jesus SO, Luna AB, da Rocha BRS, Santos MA, Neto JAF, Dias LPP, Cantanhede RCA, Morais JM, Duarte RCL, Barbosa ECB, Barbosa JMA, de Sousa RML, Dos Santos AF, Teixeira AF, Moriguchi EH, Bruscato NM, Kesties J, Vivian L, de Carli W, Shumacher M, Izar MCO, Asoo MT, Kato JT, Martins CM, Machado VA, Bittencourt CRO, de Freitas TT, Sant'Anna VAR, Lopes JD, Fischer SCPM, Pinto SL, Silva KC, Gratao LHA, Holzbach LC, Backes LM, Rodrigues MP, Deucher KLAL, Cantarelli M, Bertoni VM, Rampazzo D, Bressan J, Hermsdorff HHM, Caldas APS, Felicio MB, Honorio CR, da Silva A, Souza SR, Rodrigues PA, de Meneses TMX, Kumbier MCC, Barreto AL, Cavalcanti AB. Implementation of a Brazilian Cardioprotective Nutritional (BALANCE) Program for improvement on quality of diet and secondary prevention of cardiovascular events: A randomized, multicenter trial. Am Heart J. 2019 Sep;215:187-197. doi: 10.1016/j.ahj.2019.06.010. Epub 2019 Jun 21.

    PubMed 31349110

  • 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.

    PubMed 31296225

  • Tereza da Silva J, Bersch-Ferreira AC, Torreglosa CR, Weber B, Levy RB. Development of a dietary index based on the Brazilian Cardioprotective Nutritional Program (BALANCE). Nutr J. 2018 May 4;17(1):49. doi: 10.1186/s12937-018-0359-5.

    PubMed 29728114

  • Weber B, Bersch-Ferreira AC, Torreglosa CR, Ross-Fernandes MB, da Silva JT, Galante AP, Lara Ede S, Costa RP, Soares RM, Cavalcanti AB, Moriguchi EH, Bruscato NM, Kesties, Vivian L, Schumacher M, de Carli W, Backes LM, Reolao BR, Rodrigues MP, Baldissera DM, Tres GS, Lisboa HR, Bem JB, Reolao JB, Deucher KL, Cantarelli M, Lucion A, Rampazzo D, Bertoni V, Torres RS, Verrissimo AO, Guterres AS, Cardos AF, Coutinho DB, Negrao MG, Alencar MF, Pinho PM, Barbosa SN, Carvalho AP, Taboada MI, Pereira SA, Heyde RV, Nagano FE, Baumgartner R, Resende FP, Tabalipa R, Zanini AC, Machado MJ, Araujo H, Teixeira ML, Souza GC, Zuchinali P, Fracasso BM, Ulliam K, Schumacher M, Pierotto M, Hilario T, Carlos DM, Cordeiro CG, Carvalho DA, Goncalves MS, Vasconcelos VB, Bosquetti R, Pagano R, Romano ML, Jardim CA, de Abreu BN, Marcadenti A, Schmitt AR, Tavares AM, Faria CC, Silva FM, Fink JS, El Kik RM, Prates CF, Vieira CS, Adorne EF, Magedanz EH, Chieza FL, Silva IS, Teixeira JM, Trescastro EP, Pellegrini LA, Pinto JC, Telles CT, Sousa AC, Almeida AS, Costa AA, Carmo JA, Silva JT, Alves LV, Sales SO, Ramos ME, Lucas MC, Damiani M, Cardoso PC, Ramos SS, Dantas CF, Lopes AG, Cabral AM, Lucena AC, Medeiros AL, Terceiro BB, Leda NM, Baia SR, Pinheiro JM, Cassiano AN, Melo AN, Cavalcanti AK, Souza CV, Queiroz DJ, Farias HN, Souza LC, Santos LS, Lima LR, Hoffmann MS, Ribeiro AS, Vasconcelos DF, Dutra ES, Ito MK, Neto JA, Santos AF, Sousa RM, Dias LP, Lima MT, Modanesi VG, Teixeira AF, Estrada LC, Modanesi PV, Gomes AB, Rocha BR, Teti C, David MM, Palacio BM, Junior DG, Faria EH, Oliveira MC, Uehara RM, Sasso S, Moreira AS, Cadinha AC, Pinto CW, Castilhos MP, Costa M, Kovacs C, Magnoni D, Silva Q, Germini MF, da Silva RA, Monteiro AS, dos Santos KG, Moreira P, Amparo FC, Paiva CC, Poloni S, Russo DS, Silveira IV, Moraes MA, Boklis M, Cardoso QI, Moreira AS, Damaceno AM, Santos EM, Dias GM, Pinho CP, Cavalcanti AC, Bezerra AS, Queiroga AV, Rodrigues IG, Leal TV, Sahade V, Amaral DA, Souza DS, Araujo GA, Curvello K, Heine M, Barretto MM, Reis NA, Vasconcelos SM, Vieira DC, Costa FA, Fontes JM, Neto JG, Navarro LN, Ferreira RC, Marinho PM, Abib RT, Longo A, Bertoldi EG, Ferreira LS, Borges LR, Azevedo NA, Martins CM, Kato JT, Izar MC, Asoo MT, de Capitani MD, Machado VA, Fonzar WT, Pinto SL, Silva KC, Gratao LH, Machado SD, de Oliveira SR, Bressan J, Caldas AP, Lima HC, Hermsdorff HH, Saldanha TM, Priore SE, Feres NH, Neves Ade Q, Cheim LM, Silva NF, Reis SR, Penafort AM, de Queiros AP, Farias GM, de los Santos ML, Ambrozio CL, Camejo CN, dos Santos CP, Schirmann GS, Boemo JL, Oliveira RE, Lima SM, Bortolini VM, Matos CH, Barretta C, Specht CM, de Souza SR, Arruda CS, Rodrigues PA, Berwanger O. The Brazilian Cardioprotective Nutritional Program to reduce events and risk factors in secondary prevention for cardiovascular disease: study protocol (The BALANCE Program Trial). Am Heart J. 2016 Jan;171(1):73-81.e1-2. doi: 10.1016/j.ahj.2015.08.010. Epub 2015 Aug 15.

    PubMed 26699603

Questions about this trial

What is this clinical trial studying?

A study testing BALANCE in people with Cardiovascular Diseases, run by Hospital do Coracao at 35 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composity of Major Cardiovascular Events (time frame: up to 48 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01620398, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2018.

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