ICFAMED.
Methods | A Mediterranean diet for preventing heart failure and atrial fibrillation in hypertensive patients (ICFAMED) RCT, 24 months |
Participants | People with hypertension aged 55 to 75 years at high cardiovascular risk, but without existing CVD |
Interventions | MedDiet: Mediterranean‐style diet, dietary advice (individual and group) every three months LFD: Low‐fat diet according to American Heart Association guidelines, dietary advice (individual and group) every three months |
Outcomes | Primary: heart failure and/or atrial fibrillation Secondary: echocardiographic variables & BP variables Actual outcomes from abstracts: MedDiet: 5 CVD events (atrial fibrillation (AF) 2; ischaemic heart disease (IHD) 2; stroke 1), LFD: 11 CVD events (AF 6, IHD 2, stroke 3). The crude rate for the occurrence of events per 1000 patient‐months of follow‐up was 197 (95% CI: 06–46) for MedDiet, 451 (95% CI: 3–8.1) for LFD. The HR for patients with MedDiet compared to LFD was 044 (95% CI: 015–126, P > 005). |
Notes | Trials registration: ISRCTN27497769 Enrollment began in 2012; appears to have completed in 2017; abstract and poster publications only to date Awaiting assessment because: Unclear whether one arm was higher in saturated fat than the other, awaiting fuller publication to assess |
AF: atrial fibrillation CVD: cardiovascular disease HR: hazard ratio ICFAMED: A Mediterranean diet for preventing heart failure and atrial fibrillation in hypertensive patients IHD: Ischaemic heart disease LFD: low fat diet MedDiet: Mediterranean style diet RCT: randomised controlled trial