Woman and Man
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Extract
Background and study aims We aim to study the effects of a Mediterranean diet, as compared with a low-fat diet, on the incidence of heart failure and atrial fibrillation (irregular heart rate) in hypertensive (high blood pressure) patients at high risk of heart disease. Who can participate? Male and female patients aged between 55 and 75 with hypertension (high blood pressure), being treated with antihypertensive (blood pressure lowering) medication, and at high risk of heart disease. What does the study involve? Participants will be randomly allocated into one of two groups: the control group, who will follow a low-fat diet, or the intervention group, who will follow a Mediterranean diet. Participants will come to the medical office where the following tests will be conducted: blood pressure measurements, electrocardiogram and echocardiogram, blood and urine tests, and measurement of weight, height, waist circumference and hip contour. Participants will also attend educational talks about hypertension and healthy eating. Participants will be given a booklet which will include essential information from the talks and a seasonal menu, tailored for each group. What are the possible benefits and risks of participating? Participants will benefit from personalized dietary monitoring. No risk to the participants is foreseen, because they will only follow a healthy diet for hypertension and receive information about healthy living. We will not modify any participant's antihypertensive drug treatment. Where is the study run from? The Al-Andalus research group, which consists of general practitioners, specialists, nurses, statisticians and a dietitian. The study will be carried out at the Ronda Historica Health Center (Spain). When is the study starting and how long is it expected to run for? Recruitment will start in June 2012. Participants will be enrolled on the study for a period of 12 months. Every participant will be monitored for at least two years. Consequently, the study is expected to finish at the end of 2015. Who is funding the study? Funding has been provided by Instituto de Salud Carlos III, Consejería de Salud - Junta de Andalucía and CIBERobn. Who is the main contact? José Lapetra [email protected]
Inclusion criteria
- Cardiovascular disease (heart failure and atrial fibrillation)