Nutritional Improvement in Chronic Heart Failure Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Impact on Nutrition and Quality of Life of Patients With Heart Failure After a Nurse Intervention on Nutrition Improvement

Conditions
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Heart Failure

Intervention / Treatment
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* Dietary Supplement: Hypercaloric beverages
* Other: standard treatment
* Other: educational structured counseling


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: educational intervention and supplements<br>structured educational intervention and dietary supplements | Dietary Supplement: Hypercaloric beverages<br>* Nutritional supplement: Hypercaloric beverages<br>Other: educational structured counseling<br>* Nutritional counseling leaded to patient and caregivers<br>|
| Active Comparator: usual interventions<br>Usual treatment without nutritional supplements or structured assessment | Other: standard treatment<br>* No other than standard treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on nutritional status measured with Global Subjective Assesment |  | At inclusion , months 3 and 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change on quality of life of patients measured with Minnesota Living With Heart Failure Questionnaire, after an educational intervention and nutritional supplement |  | At inclusion , months 3 and 9 | 
| Change on meters walked in six minutes (functional capacity), after the intervention |  | At inclusion , months 3 and 9 | 
| Number of readmission. |  | at month 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional status, MNA, GSA