Nutritional Improvement in Chronic Heart Failure Patients (VAINICA)

November 5, 2015 updated by: Luis Guerra

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Servicio de Nefrología Hospital General universitario Gregorio Maranon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: educational intervention and supplements
structured educational intervention and dietary supplements
Dietary supplement: Hypercaloric beverages
Nutritional supplement: Hypercaloric beverages
Other: educational structured counseling
Nutritional counseling leaded to patient and caregivers
ACTIVE_COMPARATOR: usual interventions
Usual treatment without nutritional supplements or structured assessment
Other: standard treatment
No other than standard treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luis Guerra

Collaborators

Instituto de Salud Carlos III

Investigators

  • Principal Investigator: Luis Guerra, Nurse, Hospital General Universitario Gregorio Marañón

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

October 28, 2015

First Submitted That Met QC Criteria

November 5, 2015

First Posted (ESTIMATE)

November 9, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

November 9, 2015

Last Update Submitted That Met QC Criteria

November 5, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI11/02428

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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