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Completed

NCT Number: NCT02599935

Nutritional Improvement in Chronic Heart Failure Patients

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Servicio de Nefrología Hospital General universitario Gregorio Maranon

Madrid, 28007, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypercaloric beverages

Dietary Supplement

Nutritional supplement: Hypercaloric beverages

standard treatment

Other

No other than standard treatment

educational structured counseling

Other

Nutritional counseling leaded to patient and caregivers

Primary outcomes

  1. Change on nutritional status measured with Global Subjective Assesment

    Time frame: At inclusion , months 3 and 9

Secondary outcomes

  1. 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

  2. Change on meters walked in six minutes (functional capacity), after the intervention

    Time frame: At inclusion , months 3 and 9

  3. Number of readmission.

    Time frame: at month 12

Sponsors and collaborators

Lead sponsor

Luis Guerra

Other

Collaborators

  • Instituto de Salud Carlos III

Registry information

Official study title

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

Acronym: VAINICA

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Nov 9, 2015
Registry last updated
Nov 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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