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

Primary Purpose

Heart Failure

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MULTIDOMAIN NUTRITIONAL INTERVENTION: DIET, EXERCISE AND NUTRITIONAL SUPPLEMENTS
CONTROL
Sponsored by
Spanish Society of Cardiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring HEART FAILURE, MALNUTRITION

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    NUTRITIONAL INTERVENTION

    CONTROL

    Arm Description

    Outcomes

    Primary Outcome Measures

    COMBINED EVENT
    Time to the combined event of all-cause mortality or admission for heart failure at 6 months

    Secondary Outcome Measures

    Time to 6-month cardiovascular mortality
    Time to all-cause admission at 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
    Changes in nutritional status at 3 and 6 months post intervention
    Changes in the scores of Mini Nutritional Assessment Short Form

    Full Information

    First Posted
    June 9, 2023
    Last Updated
    June 19, 2023
    Sponsor
    Spanish Society of Cardiology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05923138
    Brief Title
    Nutritional Approach in Adults Followed up in Spanish Hospitals for Heart Failure (BOCADOS-IC)
    Acronym
    BOCADOS-IC
    Official Title
    aBOrdaje nutriCional en ADultos Seguidos en hOspitales eSpañoles Por Insuficiencia Cardiaca (BOCADOS-IC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    September 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Spanish Society of Cardiology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure
    Keywords
    HEART FAILURE, MALNUTRITION

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    264 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    NUTRITIONAL INTERVENTION
    Arm Type
    Experimental
    Arm Title
    CONTROL
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    MULTIDOMAIN NUTRITIONAL INTERVENTION: DIET, EXERCISE AND NUTRITIONAL SUPPLEMENTS
    Other Intervention Name(s)
    NUTRITION TEAM
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    CONTROL
    Intervention Description
    Standard treatment (usual recommendations in patients with heart failure)
    Primary Outcome Measure Information:
    Title
    COMBINED EVENT
    Description
    Time to the combined event of all-cause mortality or admission for heart failure at 6 months
    Time Frame
    6 MONTHS
    Secondary Outcome Measure Information:
    Title
    Time to 6-month cardiovascular mortality
    Time Frame
    6 MONTHS
    Title
    Time to all-cause admission at 6 months
    Time Frame
    6 MONTHS
    Title
    Changes in quality of life at 3 and 6 months post-intervention
    Description
    Changes in the scores of Minnesota living with heart failure questionnaire
    Time Frame
    6 MONTHS
    Title
    Changes in nutritional status at 3 and 6 months post intervention
    Description
    Changes in the scores of Mini Nutritional Assessment Short Form
    Time Frame
    6 MONTHS

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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,
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    JOSE ANGEL PEREZ-RIVERA
    Phone
    +34947281800
    Ext
    35756
    Email
    JANGEL.PEREZRIVERA@GMAIL.COM

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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