Nutritional Improvement in Chronic Heart Failure Patients (VAINICA)

Luis Guerra

Status: Completed

Conditions: Heart Failure

Treatments: Other: educational structured counseling; Dietary Supplement: Hypercaloric beverages; Other: standard treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02599935

PI11/02428

Details and patient eligibility

About

To assess the effect over the nutritional status in patients who are malnourished with chronic heart failure, of an educational intervention and the provision of nutritional supplements. Randomized clinical trial with blind assessors. Unicentric. Follow up: 12 months

Full description

Randomized clinical trial with blinded evaluators. (The evaluators will not know the group the patients are assigned. Blinded evaluators are no responsible for randomization and intervention once the patients have been randomized). Patients will be recruited from the cardiology inpatient unit of tertiary hospital, before discharge. Patients will be divided in two groups randomly:

In one arm will be held a double intervention:

• A structured educational intervention oriented to the patient and primary caregiver, with respect to dietary habits, highly energetic and healthy food, the frequency and manner of eating, exercise and programming breaks.
• supplementation with dietary supplements, distinguishing one type of product or another, depending on whether the subject to study: diabetes and or kidney failure.

In the other arm of the study was carried out regular interventions

Enrollment: 76 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients with the diagnosis of heart failure: who inadvertently lost at least 5% of their "dry weight" in the last six months and / or moderately or severely malnourished according to the GSA and / or at risk or malnourished according to Mini Nutritional Assessment.
• Willing to participate by accepting and signing an informed consent.
• On treatment with inhibitors of angiotensin converting enzyme (ACE) inhibitors and / or antagonists of angiotensin II receptors (ARBs) and / or beta blockers.

Exclusion criteria

• Concurrent active cancer diagnosed.
• Previous history Dementia or severe cognitive impairment.
• Participation in another clinical trial simultaneously.
• Social or health condition that makes the patient impossible to follow the treatment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

educational intervention and supplements

Experimental group

Description:

structured educational intervention and dietary supplements

Treatment:

Other: educational structured counseling

Dietary Supplement: Hypercaloric beverages

usual interventions

Active Comparator group

Description:

Usual treatment without nutritional supplements or structured assessment

Treatment:

Other: standard treatment