Nutritional Approach in Adults Followed up in Spanish Hospitals for Heart Failure (BOCADOS-IC)

Study Overview
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Brief Summary
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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.

Official Title
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aBOrdaje nutriCional en ADultos Seguidos en hOspitales eSpañoles Por Insuficiencia Cardiaca (BOCADOS-IC)

Conditions
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Heart Failure

Intervention / Treatment
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* Dietary Supplement: MULTIDOMAIN NUTRITIONAL INTERVENTION: DIET, EXERCISE AND NUTRITIONAL SUPPLEMENTS
* Dietary Supplement: CONTROL


Participation Criteria
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Eligibility Criteria
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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,

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NUTRITIONAL INTERVENTION<br> | Dietary Supplement: MULTIDOMAIN NUTRITIONAL INTERVENTION: DIET, EXERCISE AND NUTRITIONAL SUPPLEMENTS<br>* 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.<br>* Other names: NUTRITION TEAM;|
| Placebo Comparator: CONTROL<br> | Dietary Supplement: CONTROL<br>* Standard treatment (usual recommendations in patients with heart failure)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| COMBINED EVENT | Time to the combined event of all-cause mortality or admission for heart failure at 6 months | 6 MONTHS | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Changes in the scores of Minnesota living with heart failure questionnaire | 6 MONTHS | 
| Changes in nutritional status at 3 and 6 months post intervention | Changes in the scores of Mini Nutritional Assessment Short Form | 6 MONTHS | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HEART FAILURE, MALNUTRITION