Condition category
Circulatory System
Date applied
02/05/2012
Date assigned
12/07/2012
Last edited
28/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.isciii.es

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

Publication citations

Additional files

Editorial Notes