A Mediterranean diet for preventing heart failure and atrial fibrillation in hypertensive patients

ISRCTN ISRCTN27497769
DOI https://doi.org/10.1186/ISRCTN27497769
Secondary identifying numbers PI-0271/2010 and PI10/01690
Submission date
02/05/2012
Registration date
12/07/2012
Last edited
10/08/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

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

Contact information

Dr José Lapetra
Scientific

C/ Jerusalen, s/n
Sevilla
41007
Spain

Phone + 34 95 499 41 40
Email jlapetra@ono.com

Study information

Study designRandomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEfficacy of a Mediterranean diet in primary prevention of heart failure and atrial fibrillation in high risk hypertensive patients
Study acronymICFAMED
Study objectivesICFAMED - 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(s)Ethics and Health Research Committee of Primary Care Division of Sevilla, Spain, 05 May 2010
Health condition(s) or problem(s) studiedCardiovascular disease (heart failure and atrial fibrillation)
InterventionParticipants are randomly assigned into two equal groups:
1. Mediterranean-style diet
2. Low-fat diet according to American Heart Association guidelines
Intervention typeOther
Primary outcome measureIncidence 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 measures1. 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 study start date01/06/2012
Completion date01/06/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsn = 174 high-risk hypertensive participants
Total final enrolment180
Key inclusion criteriaParticipants 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
Key exclusion criteria1. 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
Date of first enrolment01/06/2012
Date of final enrolment01/06/2015

Locations

Countries of recruitment

  • Spain

Study participating centre

C/ Jerusalen, s/n
Sevilla
41007
Spain

Sponsor information

Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Hospital/treatment centre

C/ Sinesio Delgado, 4
Madrid
28029
Spain

Phone +34 91 822 20 00
Email oficina.informacion@isciii.es
Website http://www.isciii.es
ROR logo "ROR" https://ror.org/00ca2c886

Funders

Funder type

Hospital/treatment centre

Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) ref: PI10/01690

No information available

Ministry of Health of the Andalusian (Consejería de Salud de la Junta de Andalucía) (Spain) ref: PI0271/2010

No information available

CIBER Pathophysiology of Obesity and Nutrition (CIBER Fisiopatología de la Obesidad y Nutrición (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration

2017 poster in https://www.researchgate.net/publication/318043808_Effect_of_a_Mediterranean_Diet_on_the_Primary_Prevention_of_Atrial_Fibrillation_and_Major_Cardiovascular_Events_in_Hypertensive_Patients_whith_High_Cardiovascular_Risk_Results_of_ICFAMED_Study (added 10/08/2020)
2018 abstract in https://onlinelibrary.wiley.com/doi/full/10.1111/eci.12926 (added 10/08/2020)
IPD sharing plan

Editorial Notes

10/08/2020: Poster and abstract added to publication and dissemination plan. Total final enrolment number added.