Clinical trial NCT02599935: Nutritional Improvement in Chronic Heart Failure Patients
Official title: Impact on Nutrition and Quality of Life of Patients With Heart Failure After a Nurse Intervention on Nutrition Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Nutritional status
MNA
GSA
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2015-11-09
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change on nutritional status measured with Global Subjective Assesment
timeFrame: At inclusion , months 3 and 9
Secondary outcomes:
measure: Change on quality of life of patients measured with Minnesota Living With Heart Failure Questionnaire, after an educational intervention and nutritional supplement
timeFrame: At inclusion , months 3 and 9
measure: Change on meters walked in six minutes (functional capacity), after the intervention
timeFrame: At inclusion , months 3 and 9
measure: Number of readmission.
timeFrame: at month 12
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Servicio de Nefrología Hospital General universitario Gregorio Maranon
Study officials:
affiliation: Hospital General Universitario Gregorio Maranon
name: Luis Guerra, Nurse
role: PRINCIPAL_INVESTIGATOR
References: