Heart Failure
Conditions
Keywords
HEART FAILURE, MALNUTRITION
Brief summary
This is a randomized, controlled, open-label, prospective, multicentre clinical trial designed to assess the effects of a nutritional intervention on morbidity and mortality in patients with chronic heart failure. Through a simple 1:1 randomization process, patients will be assigned to the control group or the intervention group. Patients in the intervention group will undergo an individualised nutritional intervention program consisting of 3 pillars: diet optimization, specific recommendations ,and nutritional supplementation if nutritional targets are not achieved.
Interventions
DIETARY_SUPPLEMENTMULTIDOMAIN NUTRITIONAL INTERVENTION: DIET, EXERCISE AND NUTRITIONAL SUPPLEMENTS
Nutritional intervention (diet, dietetic recommendations and/or supplements). Participants will receive specific recommendations about diet, energetic dietetic supplementation, oral nutritional supplements, exercise... The Nutrition Team (formed by cardiologists, dieticians, nurses...) will closely monitor patients with periodic visits and reassessment of nutritional status and compliance with recommendations.
DIETARY_SUPPLEMENTCONTROL
Standard treatment (usual recommendations in patients with heart failure)
Sponsors
Spanish Society of Cardiology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 65 years with malnutrition (MNA-SF score ≤ 11) with chronic ambulatory heart failure (HF).
Exclusion criteria
* Admission for heart failure (HF) in the last month, * Chronic renal failure on dialysis. * Patients already on nutritional treatment. * Concomitant diseases which, apart from the HF itself, could lead to a life expectancy of less than 1 year, * Patients included in other clinical trials. * Patients whose clinical situation makes it impossible to perform a nutritional assessment according to the design established in the study protocol or who do not give their consent for this purpose. * Patients who during admission undergo surgical or percutaneous treatment to correct the cause of acute HF,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| COMBINED EVENT | 6 MONTHS | Time to the combined event of all-cause mortality or admission for heart failure at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to 6-month cardiovascular mortality | 6 MONTHS | — |
| Time to all-cause admission at 6 months | 6 MONTHS | — |
| Changes in quality of life at 3 and 6 months post-intervention | 6 MONTHS | Changes in the scores of Minnesota living with heart failure questionnaire |
| Changes in nutritional status at 3 and 6 months post intervention | 6 MONTHS | Changes in the scores of Mini Nutritional Assessment Short Form |
Countries
Spain
Contacts
Primary ContactJOSE ANGEL PEREZ-RIVERA
Outcome results
None listed