Nutritional Intervention Program in Malnourished Patients Admitted for Heart Failure (PICNIC)

Hospital San Juan de la Cruz

Status and phase: Terminated; Phase 3

Conditions: Mortality; Malnutrition; Nutritional Intervention; Heart Failure

Treatments: Other: Nutritional intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01472237

PICNIC-2011

Details and patient eligibility

About

The purpose of this study is to determine whether a modification of the diet of malnourished patients admitted for heart failure is beneficial in term of mortality,hospitalizations and quality of life.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients admitted for heart failure
• > 18 years old
• Malnutrition determined by MNA test (< 17 points)

Exclusion criteria

• If is not possible to perform a nutritional assessment
• Planned PCI or CABG to correct heart failure etiology

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups, including a placebo group

Nutritional intervention

Active Comparator group

Description:

It will last 6 months. Will be conducted by a physician nutrition specialist assisted by a technician in diet and nutrition. The first visit will take place during admission. The patient receives dietary advice and a customized diet designed to optimize energy intake and macro/micro-nutrients needs.

Treatment:

Other: Nutritional intervention

Care as usual

Placebo Comparator group

Description:

The patients are referred to their cardiologyst and primary care physicians

Treatment:

Other: Nutritional intervention