NCT05923138

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 264 (estimated)
• Sponsor: Spanish Society of Cardiology · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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

• Heart Failure

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2023-11-02
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2023-06-28
• Last updated: 2023-11-22

Locations

1 site across 1 country: Spain