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

Spanish Society of Cardiology

Status

Enrolling

Conditions

Heart Failure

Treatments

Dietary Supplement: CONTROL

Dietary Supplement: MULTIDOMAIN NUTRITIONAL INTERVENTION: DIET, EXERCISE AND NUTRITIONAL SUPPLEMENTS

Study type

Interventional

Funder types

Other

Identifiers

NCT05923138

SECAINC-INV-ICC 23/04 (Other Identifier)

SEC-BOCADOS-IC-2023

Details and patient eligibility

About

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.

Enrollment

264 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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,