This trial is active, not recruiting.

Conditions cardiovascular risk factors, metabolic syndrome, lifestyle modification, coronary artery disease, stroke
Treatments dietary and nutritional modification, stop smoking, regular physical activities, weight reduction to normal ranges, regular intake of polyphenols, esp. from ilex paraguayensis
Sponsor Heidelberg University
Start date May 2006
End date May 2014
Trial size 7000 participants
Trial identifier NCT00486993, AsuRiesgo


According to WHO estimations, cardiovascular diseases (CVDs) are the number one cause of death globally. More people die annually from CVDs than from any other cause. An estimated 17.5 million people died from CVDs in 2005, representing 30% of all global deaths. Of these deaths, an estimated 7.6 million were due to coronary heart disease and 5.7 million were due to stroke.

Over 80% of CVD deaths take place in low- and middle-income countries and occur almost equally in men and women. In Paraguay, prevalence of classic risk factors, as well as new ones, like the metabolic syndrome are not completely known.

Government health policies in industrialized countries are focusing on programs to modify cardiovascular risk factors. In developing countries, prevention of coronary heart disease and stroke through modification of cardiovascular risk factors are not playing a large role at the moment.

The aim of this study is to define the effects of changes in lifestyle on cardiovascular risk factors, when added to optimized standard pharmacological therapy for arterial hypertension, diabetes mellitus and hyperlipidemia, in an ambulatory urban patient population.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention

Primary Outcomes

cardiovascular mortality
time frame: one year

Secondary Outcomes

mortality, other causes
time frame: one year
acute myocardial infarction
time frame: one year
time frame: one year
acute coronary syndrome
time frame: one year

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - all ambulatory patients, with age 18 years or older Exclusion Criteria: - no exclusion criteria provided, particularly for the first, epidemiological part of the study

Additional Information

Official title Estimation of Prevalence and Assessment of the Effects of Modification of Cardiovascular Risk Factors in an Ambulatory Urban Patient Population
Principal investigator Derliz Mereles, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Heidelberg University.