Nutritional Approach in Adults Followed up in Spanish Hospitals for Heart Failure (BOCADOS-IC)
NCT ID: NCT05923138
Last Updated: 2023-11-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
264 participants
INTERVENTIONAL
2023-11-02
2024-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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NUTRITIONAL INTERVENTION
MULTIDOMAIN 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.
CONTROL
CONTROL
Standard treatment (usual recommendations in patients with heart failure)
Interventions
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MULTIDOMAIN 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.
CONTROL
Standard treatment (usual recommendations in patients with heart failure)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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,
65 Years
ALL
No
Sponsors
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Spanish Society of Cardiology
OTHER
Responsible Party
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JOSE ANGEL PEREZ RIVERA
Principal Investigator
Locations
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Hospital Universitario de Burgos
Burgos, , Spain
Countries
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Central Contacts
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Facility Contacts
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JOSE ANGEL PEREZ RIVERA
Role: primary
Other Identifiers
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SECAINC-INV-ICC 23/04
Identifier Type: OTHER
Identifier Source: secondary_id
SEC-BOCADOS-IC-2023
Identifier Type: -
Identifier Source: org_study_id