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| Name | Class |
|---|---|
| University of Navarra | OTHER |
| University Hospital Virgen de las Nieves | OTHER |
| Hospital General Universitario de Alicante | OTHER |
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Background: Atrial fibrillation (AF) is the most frequent cardiac arrhythmia and represents a high priority public health problem, as in a few decades it will become a possibly unsustainable load for the national health system. Preventive and therapeutic strategies based on the best possible scientific evidence are required. Ablation therapy, despite being the most effective approach, is associated with a 30-35% arrhythmic recurrence rate. An intervention with Mediterranean diet and extra virgin olive oil (EVOO) has proven effective in primary prevention and reduced the incidence of AF in high-risk subjects in a recent, large, randomized trial (PREDIMED).
Methods: Parallel, randomized, multicenter nutritional intervention trial in 640 patients with AF treated with catheter ablation. Two groups will be randomized in a 1:1 ratio: 1) intervention with Mediterranean diet and EVOO; 2) usual care (control group). The primary objective will be the incidence of atrial tachyarrhythmias for two years after ablation. At least 190 recurrences are expected after 2 years (median) of follow-up. A relative risk of 0.7 is assumed and statistical power of 80%. Follow-up visits will be scheduled at 3, 6, 12, 18 and 24 months. In addition to the in-person visits, event monitors will be used to document episodes. Dietary intervention will be carried out by nutritionists who will use methods adapted from the PREDIMED trial with contacts every 2 months. 1 liter of EVOO per week will be provided for free in the intervention arm. Inflammatory markers will be analyzed in both groups during follow-up. Cox models will be used to estimate adjusted hazard ratios.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mediterranean diet plus extra virgin olive oil | Experimental | These patients will receive 1 liter of EVOO per week free of charge and dietary advice on how to follow a Mediterranean diet with contacts every two months. |
|
| no specific diet | No Intervention | The control group will be assigned to the usual care and patients assigned to this group will not receive any special intervention to follow a particular diet, as occurs in the current clinical practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mediterranean diet plus extra virgin olive oil | Dietary Supplement | The patients in the intervention group will receive 1 liter of EVOO per week free of charge and dietary advice on how to follow a Mediterranean diet with contacts every two months. Dietary intervention will be carried out by nutritionists with previous experience in the PREDIMED study. All of them were registered, trained and certified for developing the PREDIMED intervention protocol that is similar to the one to be carried out in this study. The theoretical sessions with patients about dietary education shall be conducted in telephone form, using the internet and sending comprehensive written material to their homes that includes recipes, shopping lists, menus and explanations of typical food in the Mediterranean diet |
| Measure | Description | Time Frame |
|---|---|---|
| atrial tachyarrhythmias documented by electrocardiogram or recorder device | Atrial tachyarrhythmia is defined at any fast rate (>100 bpm) of supraventricular origin lasting more than 30 seconds and that is documented by ECG, Holter or event monitor. | mean follow up of 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Atrial fibrillation documented by electrocardiogram or recorder device | AF is defined at any irregular atrial rhythm lasting more than 30 seconds and that is documented by ECG, Holter or event monitor. AF may or may not be symptomatic. | mean follow up of 2 years |
| changes in Inflammatory markers in blood samples |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Miguel A Martinez González, MD, PhD, MPH | University of Navarra | Study Chair |
| Jesus Almendral Garrote, MD, PhD, FESC | Fundación HM | Study Director |
| Teresa Barrio Lopez, MD, PhD | Fundación HM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Teresa Barrio Lopez | Madrid | 28033 | Spain | |||
| Teresa Barrio López |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24787471 | Result | Martinez-Gonzalez MA, Toledo E, Aros F, Fiol M, Corella D, Salas-Salvado J, Ros E, Covas MI, Fernandez-Crehuet J, Lapetra J, Munoz MA, Fito M, Serra-Majem L, Pinto X, Lamuela-Raventos RM, Sorli JV, Babio N, Buil-Cosiales P, Ruiz-Gutierrez V, Estruch R, Alonso A; PREDIMED Investigators. Extravirgin olive oil consumption reduces risk of atrial fibrillation: the PREDIMED (Prevencion con Dieta Mediterranea) trial. Circulation. 2014 Jul 1;130(1):18-26. doi: 10.1161/CIRCULATIONAHA.113.006921. Epub 2014 Apr 30. | |
| 23432189 |
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Prior to ablation blood samples will be collected for determination of inflammatory parameters in a subsample of the study (neutrophil to lymphocyte ratio, TNF-alpha, fibrinogen, IL-2, IL6, IL-8, C-reactive protein). At 3 and 12 months of follow-up the determination of these parameters will be repeated. |
| 1 year follow up |
| Changes in quality of life measured by SF-36 questionnaire | Change in quality of life during the follow up measured by SF-36 questionnaire | mean follow up of 2 years |
| Madrid |
| 28033 |
| Spain |
| Result |
| Estruch R, Ros E, Salas-Salvado J, Covas MI, Corella D, Aros F, Gomez-Gracia E, Ruiz-Gutierrez V, Fiol M, Lapetra J, Lamuela-Raventos RM, Serra-Majem L, Pinto X, Basora J, Munoz MA, Sorli JV, Martinez JA, Martinez-Gonzalez MA; PREDIMED Study Investigators. Primary prevention of cardiovascular disease with a Mediterranean diet. N Engl J Med. 2013 Apr 4;368(14):1279-90. doi: 10.1056/NEJMoa1200303. Epub 2013 Feb 25. |
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| 33284131 | Derived | Goni L, de la O V, Barrio-Lopez MT, Ramos P, Tercedor L, Ibanez-Criado JL, Castellanos E, Ibanez Criado A, Macias Ruiz R, Garcia-Bolao I, Almendral J, Martinez-Gonzalez MA, Ruiz-Canela M. A Remote Nutritional Intervention to Change the Dietary Habits of Patients Undergoing Ablation of Atrial Fibrillation: Randomized Controlled Trial. J Med Internet Res. 2020 Dec 7;22(12):e21436. doi: 10.2196/21436. |
| 31809992 | Derived | Barrio-Lopez MT, Ruiz-Canela M, Ramos P, Tercedor L, Ibanez Criado JL, Ortiz M, Goni L, Ibanez Criado A, Macias-Ruiz R, Garcia-Bolao I, Martinez-Gonzalez MA, Almendral J. PREvention of recurrent arrhythmias with Mediterranean diet (PREDIMAR) study in patients with atrial fibrillation: Rationale, design and methods. Am Heart J. 2020 Feb;220:127-136. doi: 10.1016/j.ahj.2019.10.009. Epub 2019 Oct 26. |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D038441 | Diet, Mediterranean |
| ID | Term |
|---|---|
| D000095500 | Diet, Plant-Based |
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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