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

November 21, 2023 updated by: JOSE ANGEL PEREZ RIVERA, Spanish Society of Cardiology

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Burgos, Spain
        • Recruiting
        • Hospital Universitario de Burgos
        • Contact:
          • JOSE ANGEL PEREZ RIVERA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: CONTROL
Dietary supplement: CONTROL
Standard treatment (usual recommendations in patients with heart failure)
Experimental: NUTRITIONAL INTERVENTION
Dietary supplement: 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.
Other Names:
  • NUTRITION TEAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COMBINED EVENT
Time Frame: 6 MONTHS
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
Time Frame: 6 MONTHS
6 MONTHS
Time to all-cause admission at 6 months
Time Frame: 6 MONTHS
6 MONTHS
Changes in quality of life at 3 and 6 months post-intervention
Time Frame: 6 MONTHS
Changes in the scores of Minnesota living with heart failure questionnaire
6 MONTHS
Changes in nutritional status at 3 and 6 months post intervention
Time Frame: 6 MONTHS
Changes in the scores of Mini Nutritional Assessment Short Form
6 MONTHS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spanish Society of Cardiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 9, 2023

First Submitted That Met QC Criteria

June 19, 2023

First Posted (Actual)

June 28, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEC-BOCADOS-IC-2023
  • SECAINC-INV-ICC 23/04 (Other Identifier: SOCIEDAD ESPAÑOLA DE CARDIOLOGIA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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