Plain English Summary
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
jlapetra@ono.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr José Lapetra
ORCID ID
Contact details
C/ Jerusalen
s/n
Sevilla
41007
Spain
+ 34 95 499 41 40
jlapetra@ono.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PI-0271/2010 and PI10/01690
Study information
Scientific title
Efficacy of a Mediterranean diet in primary prevention of heart failure and atrial fibrillation in high risk hypertensive patients
Acronym
ICFAMED
Study hypothesis
ICFAMED - Insuficiencia Cardiaca (Heart Failure), Fibrilación Auricular (Atrial Fibrillation) and dieta MEDiterránea (MEDiterranean diet).
A Mediterranean dietary pattern versus a low-fat diet, applied to high-risk hypertensive patients who have not yet developed heart failure (HF) or atrial fibrillation (AF) reduces the incidence of both cardiac complications, improves echocardiographic parameters with prognostic value, and lowers clinic and ambulatory blood pressure.
Ethics approval
Ethics and Health Research Committee of Primary Care Division of Sevilla, Spain, 05 May 2010
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cardiovascular disease (heart failure and atrial fibrillation)
Intervention
Participants are randomly assigned into two equal groups:
1. Mediterranean-style diet
2. Low-fat diet according to American Heart Association guidelines
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Incidence of heart failure and/or atrial fibrillation at baseline, after 1 year of follow-up and after two years of follow-up (end of study)
Secondary outcome measures
1. Ecocardiographic variables:
1.1. Left ventricular mass
1.2. Systolic function
1.3. Diastolic function
1.4. Myocardial performance index
2.Blood pressure variables:
2.1. Clinic blood pressure (BPc)
2.2. Ambulatory blood pressure (ABP), obtained by ambulatory blood pressure monitoring for 24 hours
2.3. Performance of blood pressure during sleep (dipper, non dipper, extreme dipper, raiser)
2.4. Ambulatory pulse pressure
2.5. White-coat phenomenon (differences BPc ABP > 20 mmHg for systolic and/or BPc ABP > 10 mmHg for diastolic BP)
Measured at baseline, after 1 year of follow-up and after two years of follow-up (end of study).
Overall trial start date
01/06/2012
Overall trial end date
01/06/2015
Reason abandoned
Eligibility
Participant inclusion criteria
Participants are community-dwelling hypertensive patients, 55 to 75 years old, at high cardiovascular risk, with pharmacological treatment antihypertensive, without a personal documented history of cardiovascular disease (CVD): coronary heart disease, stroke, heart failure (HF) or atrial fibrillation (AF), who fulfill at least one of the two following criteria:
1. Type 2 diabetes mellitus
2. Two or more of the cardiovascular risk factors:
2.1. Current smoker
2.2. Lipid disorders (low density lipoprotein cholesterol [LDL-cholesterol] ≥ 160 mg/dl or high density lipoprotein cholesterol [HDL -cholesterol] < 40 mg/dl or treatment with hypolipidemic drugs)
2.3. Obesity (body mass index ≥ 30 Kg/m2)
2.4. Family history of premature CVD
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
n = 174 high-risk hypertensive participants
Participant exclusion criteria
1. Previous history of cardiovascular disease (coronary heart disease, stroke, HF or AF)
2. Body mass index > 40 Kg/m2
3. Severe chronic disease with poor prognosis
4. Illegal drug use or chronic alcoholism
5. Physical limitations, mental or intellectual berriers to participate in the trial
6. Low predicted likelihood of changing dietary habits
7. Any condition that may affect the development of the trial
Recruitment start date
01/06/2012
Recruitment end date
01/06/2015
Locations
Countries of recruitment
Spain
Trial participating centre
C/ Jerusalen, s/n
Sevilla
41007
Spain
Sponsor information
Organisation
Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Sponsor details
C/ Sinesio Delgado
4
Madrid
28029
Spain
+34 91 822 20 00
oficina.informacion@isciii.es
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) ref: PI10/01690
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ministry of Health of the Andalusian (Consejería de Salud de la Junta de Andalucía) (Spain) ref: PI0271/2010
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
CIBER Pathophysiology of Obesity and Nutrition (CIBER Fisiopatología de la Obesidad y Nutrición (Spain)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary