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

NCT05923138 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2023-11-22

No results posted yet for this study

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.

Conditions

Interventions

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.

DIETARY_SUPPLEMENT

CONTROL

Standard treatment (usual recommendations in patients with heart failure)

Sponsors & Collaborators

  • Spanish Society of Cardiology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-02
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05923138 on ClinicalTrials.gov