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Life sciences · Interventional Study
ClinicalTrials.gov · October 21, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07885514). This is a study registration, not published results. Lead sponsor: Hospital Severo Ochoa. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 214 participants (ESTIMATED). Conditions: Heart Failure, Heart Failure Preserved Ejection Fraction, Heart Failure, Diastolic (HFpEF), Chronic Inflammation. Interventions: BEHAVIORAL: Structured exercise training program; BEHAVIORAL: Mediterranean diet counseling; OTHER: Standard heart failure management. Primary outcome measures: Hierarchical composite of cardiovascular death, recurrent heart failure hospitalizations, 6-minute walk test distance, and quality of life (KCCQ) at 12 months , 12 months. Brief 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.