Nutritional Improvement in Chronic Heart Failure Patients

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: standard treatment; Dietary Supplement: Hypercaloric beverages; Other: educational structured counseling

• Registration Number: NCT02599935
• Lead Sponsor: Luis Guerra

Brief Summary

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

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

Study Timeline

• Study Start: 2011-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Study First Submitted: 2015-10-28
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-05
• Last Update Submitted: 2015-11-05
• Study First Posted: 2015-11-09
• Last Update Posted: 2015-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual interventions	standard treatment	Usual treatment without nutritional supplements or structured assessment
educational intervention and supplements	Hypercaloric beverages	structured educational intervention and dietary supplements
educational intervention and supplements	educational structured counseling	structured educational intervention and dietary supplements

Primary Outcome Measures

Name	Time	Method
Change on nutritional status measured with Global Subjective Assesment	At inclusion , months 3 and 9

Secondary Outcome Measures

Name	Time	Method
Number of readmission.	at month 12
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

Trial Locations

Locations (1)

Servicio de Nefrología Hospital General universitario Gregorio Maranon; 🇪🇸 Madrid, Spain