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

Heart Failure Clinical Trial

— BOCADOS-IC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05923138
• Other study ID #: SEC-BOCADOS-IC-2023
• Secondary ID: SECAINC-INV-ICC
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Spanish Society of Cardiology
• Contact: JOSE ANGEL PEREZ-RIVERA
• Phone: +34947281800
• Email: JANGEL.PEREZRIVERA[@]GMAIL.COM
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 264
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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,

Related Conditions & MeSH terms

• Heart Failure

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.
• CONTROL
Standard treatment (usual recommendations in patients with heart failure)

Locations

Country	Name	City	State
Spain	Hospital Universitario de Burgos	Burgos

Sponsors (1)

Lead Sponsor	Collaborator
Spanish Society of Cardiology

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COMBINED EVENT	Time to the combined event of all-cause mortality or admission for heart failure at 6 months	6 MONTHS
Secondary	Time to 6-month cardiovascular mortality		6 MONTHS
Secondary	Time to all-cause admission at 6 months		6 MONTHS
Secondary	Changes in quality of life at 3 and 6 months post-intervention	Changes in the scores of Minnesota living with heart failure questionnaire	6 MONTHS
Secondary	Changes in nutritional status at 3 and 6 months post intervention	Changes in the scores of Mini Nutritional Assessment Short Form	6 MONTHS