Brazilian Cardioprotective Diet Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Hospital do Coracao
Sponsor:
Information provided by (Responsible Party):
Instituto de Ensino e Pesquisa, Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT01620398
First received: June 13, 2012
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

There are no studies exploring the benefits of a diet composed of typical Brazilian food in the secondary prevention of cardiovascular diseases. Therefore, the aim of this study is to evaluate the effectiveness of the Brazilian Cardioprotective Diet in reducing risk factors and events in the secondary prevention of cardiovascular diseases.


Condition Intervention
Cardiovascular Diseases
Behavioral: Brazilian Cardioprotective Diet
Behavioral: Cardioprotective diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Brazilian Cardioprotective Diet in Reducing Events and Risk Factors in Secondary Prevention for Cardiovascular Disease: A Randomized Clinical Trial

Further study details as provided by Hospital do Coracao:

Primary Outcome Measures:
  • MACE [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Major cardiovascular events


Secondary Outcome Measures:
  • Total cholesterol [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Cholesterol, LDL [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Blood Glucose [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Blood pressure [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    Body mass index

  • WC [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    waist circumference


Estimated Enrollment: 1720
Study Start Date: February 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brazilian Cardioprotective Diet Behavioral: Brazilian Cardioprotective Diet

The patients receive nutritional counseling guided by brazilian cardiovascular disease treatment guidelines, prioritizing typical Brazilian foods, which are easily available for the entire population. Furthermore, Brazilian recipes are adapted so that they can remain in the daily lives of individuals.

Te contact between the dietitian and the patient is monthly (4 in person contact and 8 telephone contact).

Other Names:
  • DICA BRAZIL;
  • PABC;
Active Comparator: Cardioprotective diet Behavioral: Cardioprotective diet

The patients receive nutritional counseling guided by brazilian cardiovascular disease treatment guidelines. In this group, it is possible to prescribe any food, even if it is not typical or easily available for the population.

Te contact between the dietitian and the patient occurs 3 times in person and 2 times by telephone.

Other Name: Usual cardioprotective diet treatment

Detailed Description:

Cardiovascular diseases (CVD) are the leading cause of death in Brazil and worldwide. Evidence showed that the diet is effective in primary and secondary prevention of CVD. However, there are no studies exploring the benefits of a diet composed of typical Brazilian food. The objective of this study is to evaluate the effectiveness of the Brazilian Cardioprotective Diet in reducing risk factors and events in the secondary prevention of cardiovascular diseases.

This is a randomized clinical trial will include 1720 patients with CVD. Participants will be randomized into two groups: A) patients receives the Brazilian Cardioprotective Diet. In this group the patient will be followed by four in person contact and by monthly telephone contact with nutritionist; B) patients receives usual CVD nutritional counseling treatment. In this group the patient will be followed by three in person contact and by two annual telephone contact with a health professional. The outcomes include reduction of cardiac arrest, myocardial infarction, stroke, revascularization, amputation for peripheral arterial disease, angina, or death. The groups will be monitored over 12 months and comparisons made with the use of mixed linear models considering the dependence between measurements of the same patient.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any evidence of coronary artery disease (CAD) over the past 10 years, as defined by any of the following criteria:

    • History of angina (clinical diagnosis, even without exams)
    • History of stroke
    • History of abnormal segmental wall motion in cardiac echocardiography (even without symptoms) or a fixed segmental defect in radionuclide imaging test (even if no symptoms)
    • History of a positive stress test with radionuclide stress test on echocardiography or pharmacologic cardiovascular stress testing demonstrating ischemic heart disease
    • History of coronary angiography or coronary angiography atherosclerotic stenosis ≥ 50% diameter in any coronary artery
    • ECG with pathological Q-waves in two contiguous leads.
  • Any evidence of stroke or TIA in the past 10 years, as defined by any of the following criteria:

    • Medical diagnosis of stroke or TIA
    • Evidence of previous stroke
  • Peripheral Arterial Disease (PAD) in the last 10 years, defined by a diagnosis of current or previous history of any of the following criteria:

    • Intermittent claudication
    • amputation
    • Vascular surgery for atherosclerotic disease
    • Value ankle/arm <0.90 for systolic blood pressure in either leg at rest
    • Angiography or Doppler showing> 70% stenosis in an artery noncardiac
  • Current or previous hospitalization for unstable angina

Exclusion Criteria:

  • Refusal to provide Informed Consent Statement
  • neurocognitive or psychiatric condition that prevents obtaining reliable clinical data (defined by clinical trial investigators)
  • Life expectancy less than 6 months
  • Pregnancy or lactation
  • Severe hepatic encephalopathy
  • Renal Failure with indication for dialysis
  • Congestive heart failure
  • Patients with organ transplants prior
  • Wheelchair
  • Difficulty in receiving oral diet
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620398

Contacts
Contact: Bernardete Weber, PhD 55-11-3053-6611 ext 1124 bweber@hcor.com.br
Contact: Otávio Berwanger, MD, PhD 55-11-3053-6611 ext 8201 oberwanger@hcor.com.br

Locations
Brazil
Hospital Universitario Pedro Ernesto Recruiting
Rio de Janeiro, Brazil
Contact: Annie Seixas Moreira, Doctor    552123340150      
Principal Investigator: Annie Mreira, PhD         
Sponsors and Collaborators
Hospital do Coracao
Investigators
Principal Investigator: Bernardete Berwanger, PhD Hospital do Coração
Principal Investigator: Otávio Berwanger, MD, PhD Hospital do Coração
Study Chair: Rafael M Soares, MSc Hospital do Coração
Study Chair: Rosana P Costa, MSc Hospital do Coração
Study Chair: Maria Beatriz R Fernandes Hospital do Coração
Study Chair: Enilda Lara, MSc Hopsital do Coração
Study Chair: Camila R Torreglosa Hospital do Coração
Study Chair: Ângela Cristine B Ferreira, MSc Hospital do Coração
  More Information

No publications provided

Responsible Party: Instituto de Ensino e Pesquisa, Research Institute HCor, Hospital do Coracao
ClinicalTrials.gov Identifier: NCT01620398     History of Changes
Other Study ID Numbers: BCDT
Study First Received: June 13, 2012
Last Updated: February 24, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Hospital do Coracao:
cardiovascular diseases
secondary prevention
diet

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 16, 2014