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NCT07885514

Exercise, Mediterranean Diet and Inflammation in Heart Failure

Sponsor: Hospital Severo Ochoa

View on ClinicalTrials.gov

Summary

This randomized clinical trial will test whether a multimodal anti-inflammatory program added to standard treatment improves the prognosis of patients with heart failure who have recently been hospitalized or visited the emergency department for worsening heart failure. The program combines two parts: a structured physical exercise plan and a Mediterranean diet plan, adapted to each patient. A total of 214 adults with heart failure and mildly reduced or preserved ejection fraction (LVEF 40% or higher), recent worsening of heart failure, and elevated inflammatory markers (C-reactive protein) will take part. Patients with frailty or malnutrition are excluded from the study. Patients will be recruited from heart failure clinics of participating Spanish hospitals. After agreeing to participate, patients will be randomly assigned to one of two groups: one group will continue their usual heart failure treatment, and the other will follow the same treatment plus the exercise and nutrition program delivered remotely by trained professionals for 12 months. The main question is whether the multimodal program reduces the combined occurrence of cardiovascular death, repeated heart failure hospitalizations, worsening exercise capacity (6-minute walk test), or worsening quality of life (Kansas City Cardiomyopathy Questionnaire) at 12 months. The study will also check whether the program lowers blood inflammatory and heart failure biomarkers (NT-proBNP, CA125), improves heart function on echocardiography, and whether patients' adherence to the program affects the results. All participants will continue to receive standard heart failure care; no medication is being tested, and the intervention consists of lifestyle coaching delivered by telephone or video calls.

Official title: Effects of Multimodal Approach to Inflammation Versus Standard Treatment on the Prognosis of Patients With Heart Failure and Mildly Reduced or Preserved Ejection Fraction After Decompensation: FLARE-HF Randomized Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

214

Start Date

2026-11

Completion Date

2028-12

Last Updated

2026-10-21

Healthy Volunteers

Conditions

Heart Failure Heart Failure Preserved Ejection Fraction Heart Failure, Diastolic (HFpEF)Chronic Inflammation

Interventions

BEHAVIORAL

Structured exercise training program

Structured, progressive physical exercise program prescribed and supervised by trained exercise professionals. Delivered through remote/virtual visits with individualized recommendations and adherence monitoring, starting within 10 days of randomization and continuing for 12 months. Added to standard heart failure management.

BEHAVIORAL

Mediterranean diet counseling

Individualized Mediterranean diet counseling by trained nutrition professionals. Delivered through remote/virtual visits with adherence monitoring, for 12 months. Added to standard heart failure management.

OTHER

Standard heart failure management

Usual recommendations and guideline-directed management for heart failure at the participating center's HF unit (guideline-directed medical therapy and structured clinical follow-up) for 12 months. No lifestyle intervention added beyond standard care.

Inclusion Criteria: * Heart failure with left ventricular ejection fraction (LVEF) \>=40%, diagnosed according to current clinical guidelines; LVEF measured by echocardiogram within the 3 months before inclusion. If LVEF \>=50%, evidence of structural heart disease is required (at least one of: left atrial area \>=4 cm2/m2, left atrial volume \>30 mL/m2, or indexed left ventricular mass). * At least one episode of heart failure decompensation within the 4 weeks before inclusion, defined as: hospitalization for HF, emergency department visit requiring intravenous diuretics (ED or HF day unit), and/or intensification of oral treatment after such a visit, and/or worsening HF signs/symptoms during outpatient follow-up. * NT-proBNP \>=300 pg/mL in sinus rhythm or \>=900 pg/mL in atrial fibrillation (permanent or persistent), measured within the last month before inclusion. * NYHA functional class I-III at inclusion. * Systemic inflammation at inclusion, defined as C-reactive protein \>=2 mg/L and neutrophil-to-lymphocyte ratio (NLR) \>=3 (NLR = total neutrophil count / total lymphocyte count). * Basic ability to use electronic devices (smartphone, tablet or computer) and internet access. Exclusion Criteria: * Frailty (FRAIL scale \>=3) at inclusion. * Malnutrition (MNA-SF \<7) at inclusion. * Concomitant disease with expected survival \<1 year. * Planned cardiac surgery within the next 3 months. * Severe valvular heart disease (stenosis or regurgitation) at inclusion. * Acute decompensated heart failure at inclusion (worsening signs/symptoms requiring intravenous diuretics and/or treatment intensification at the time of inclusion). * Implantable cardioverter-defibrillator with shocks delivered within the last 3 months. * Chronic use of systemic anti-inflammatory drugs or immunosuppressants. * Absolute contraindication to structured physical exercise, including: unstable angina; acute thromboembolism or embolic event within the last month; active endocarditis; acute myocarditis or pericarditis; acute aortic dissection or Marfan syndrome; acute systemic illness or fever; uncontrolled hypertension (resting SBP \>=160 mmHg and/or DBP \>=100 mmHg); uncontrolled tachyarrhythmia (resting heart rate \>120 bpm); third-degree atrioventricular block without pacemaker; hypertrophic cardiomyopathy with severe obstruction; progressive worsening of exercise tolerance or resting dyspnea in the last 3-5 days; significant ischemia (myocardial or lower-limb) at low workloads (\<2 METs or 50 W); poorly controlled diabetes mellitus, active proliferative retinopathy or moderate/worsening non-proliferative retinopathy.