Nutritional Improvement in Chronic Heart Failure Patients (VAINICA)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hypercaloric beverages
standard treatment
educational structured counseling
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Nutritional status, MNA, GSA
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.
Sites / Locations
- Servicio de Nefrología Hospital General universitario Gregorio Maranon
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
educational intervention and supplements
usual interventions
Arm Description
structured educational intervention and dietary supplements
Usual treatment without nutritional supplements or structured assessment
Outcomes
Primary Outcome Measures
Change on nutritional status measured with Global Subjective Assesment
Secondary Outcome Measures
Change on quality of life of patients measured with Minnesota Living With Heart Failure Questionnaire, after an educational intervention and nutritional supplement
Change on meters walked in six minutes (functional capacity), after the intervention
Number of readmission.
Full Information
NCT ID
NCT02599935
First Posted
October 28, 2015
Last Updated
November 5, 2015
Sponsor
Luis Guerra
Collaborators
Instituto de Salud Carlos III
1. Study Identification
Unique Protocol Identification Number
NCT02599935
Brief Title
Nutritional Improvement in Chronic Heart Failure Patients
Acronym
VAINICA
Official Title
Impact on Nutrition and Quality of Life of Patients With Heart Failure After a Nurse Intervention on Nutrition Improvement
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luis Guerra
Collaborators
Instituto de Salud Carlos III
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Nutritional status, MNA, GSA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
educational intervention and supplements
Arm Type
Experimental
Arm Description
structured educational intervention and dietary supplements
Arm Title
usual interventions
Arm Type
Active Comparator
Arm Description
Usual treatment without nutritional supplements or structured assessment
Intervention Type
Dietary Supplement
Intervention Name(s)
Hypercaloric beverages
Intervention Description
Nutritional supplement: Hypercaloric beverages
Intervention Type
Other
Intervention Name(s)
standard treatment
Intervention Description
No other than standard treatment
Intervention Type
Other
Intervention Name(s)
educational structured counseling
Intervention Description
Nutritional counseling leaded to patient and caregivers
Primary Outcome Measure Information:
Title
Change on nutritional status measured with Global Subjective Assesment
Time Frame
At inclusion , months 3 and 9
Secondary Outcome Measure Information:
Title
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
Title
Change on meters walked in six minutes (functional capacity), after the intervention
Time Frame
At inclusion , months 3 and 9
Title
Number of readmission.
Time Frame
at month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luis Guerra, Nurse
Organizational Affiliation
Hospital General Universitario Gregorio Maranon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Servicio de Nefrología Hospital General universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
12. IPD Sharing Statement
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Nutritional Improvement in Chronic Heart Failure Patients
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