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

Efficacy of a Mediterranean diet in primary prevention of heart failure and atrial fibrillation in high risk hypertensive patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN27497769

Enrollment

174

Registered

2012-07-12

Start date

2012-06-01

Completion date

Unknown

Last updated

2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular disease (heart failure and atrial fibrillation) Circulatory System Heart failure

Interventions

Participants are randomly assigned into two equal groups: 1. Mediterranean-style diet 2. Low-fat diet according to American Heart Association guidelines

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026