Nutritional Improvement in Chronic Heart Failure Patients

Heart Failure Clinical Trial

— VAINICA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02599935
• Other study ID #: PI11/02428
• Status: Completed
• Phase: N/A
• First received: October 28, 2015
• Last updated: November 5, 2015
• Start date: September 2011
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Hospital General Universitario Gregorio Marañon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Dietary Supplement:
• Hypercaloric beverages
Nutritional supplement: Hypercaloric beverages

Other:
• standard treatment
No other than standard treatment
• educational structured counseling
Nutritional counseling leaded to patient and caregivers

Locations

Country	Name	City	State
Spain	Servicio de Nefrología Hospital General universitario Gregorio Maranon	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Luis Guerra	Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on nutritional status measured with Global Subjective Assesment		At inclusion , months 3 and 9	No
Secondary	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	No
Secondary	Change on meters walked in six minutes (functional capacity), after the intervention		At inclusion , months 3 and 9	No
Secondary	Number of readmission.		at month 12	No