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

Not Applicable

Recruiting

• Conditions: Heart Failure
• Interventions: Dietary Supplement: CONTROL

• Registration Number: NCT05923138
• Lead Sponsor: Spanish Society of Cardiology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-19
• Study First Posted: 2023-06-28
• Status Verified: 2023-11
• Study Start: 2023-11-02
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22
• Primary Completion: 2024-09
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 264

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CONTROL	CONTROL	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in nutritional status at 3 and 6 months post intervention	6 MONTHS	Changes in the scores of Mini Nutritional Assessment Short Form
Time to all-cause admission at 6 months	6 MONTHS
Time to 6-month cardiovascular mortality	6 MONTHS
Changes in quality of life at 3 and 6 months post-intervention	6 MONTHS	Changes in the scores of Minnesota living with heart failure questionnaire

Trial Locations

Locations (1)

Hospital Universitario de Burgos; 🇪🇸 Burgos, Spain