A Mediterranean diet for preventing heart failure and atrial fibrillation in hypertensive patients
| ISRCTN | ISRCTN27497769 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN27497769 |
| Protocol serial number | PI-0271/2010 and PI10/01690 |
| Sponsor | Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) |
| Funders | Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) ref: PI10/01690, Ministry of Health of the Andalusian (Consejería de Salud de la Junta de Andalucía) (Spain) ref: PI0271/2010, CIBER Pathophysiology of Obesity and Nutrition (CIBER Fisiopatología de la Obesidad y Nutrición (Spain) |
- 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
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
Scientific
C/ Jerusalen, s/n
Sevilla
41007
Spain
| Phone | + 34 95 499 41 40 |
|---|---|
| jlapetra@ono.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Efficacy of a Mediterranean diet in primary prevention of heart failure and atrial fibrillation in high risk hypertensive patients |
| Study acronym | ICFAMED |
| Study objectives | 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(s) | Ethics and Health Research Committee of Primary Care Division of Sevilla, Spain, 05 May 2010 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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) |
| Key secondary outcome measure(s) |
1. Ecocardiographic variables: |
| Completion date | 01/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 174 |
| Total final enrolment | 180 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 01/06/2015 |
Locations
Countries of recruitment
- Spain
Study participating centre
41007
Spain
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/08/2020: Poster and abstract added to publication and dissemination plan. Total final enrolment number added.
