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Nutritional Intervention Program in Malnourished Patients Admitted for Heart Failure (PICNIC)

This study is currently recruiting participants.
Verified November 2011 by Hospital San Juan de la Cruz
Sponsor:
Information provided by (Responsible Party):
Juan Luis Bonilla Palomas, Hospital San Juan de la Cruz
ClinicalTrials.gov Identifier:
NCT01472237
First received: November 11, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted

November 11, 2011
November 11, 2011
November 2011
December 2012   (final data collection date for primary outcome measure)
Mortality and heart failure hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Nutritional Intervention Program in Malnourished Patients Admitted for Heart Failure
Randomized Cotrolled Trial of Nutritional Intervention Program in Malnourished (Mini Nutritional Assessment < 17) Patients Admitted for Heart Failure

The purpose of this study is to determine whether a modification of the diet of malnourished patients admitted for heart failure is beneficial in term of mortality,hospitalizations and quality of life.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
  • Heart Failure
  • Malnutrition
  • Nutritional Intervention
  • Mortality
Other: Nutritional intervention
Modification of diet
  • Active Comparator: Nutritional intervention
    It will last 6 months. Will be conducted by a physician nutrition specialist assisted by a technician in diet and nutrition. The first visit will take place during admission. The patient receives dietary advice and a customized diet designed to optimize energy intake and macro/micro-nutrients needs.
    Intervention: Other: Nutritional intervention
  • Placebo Comparator: Care as usual
    The patients are referred to their cardiologyst and primary care physicians
    Intervention: Other: Nutritional intervention
Bonilla-Palomas JL, Gámez-López AL, Anguita-Sánchez MP, Castillo-Domínguez JC, García-Fuertes D, Crespin-Crespin M, López-Granados A, Suárez de Lezo J. [Impact of malnutrition on long-term mortality in hospitalized patients with heart failure]. Rev Esp Cardiol. 2011 Sep;64(9):752-8. Epub 2011 Jun 8. Spanish.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
182
December 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients admitted for heart failure
  • > 18 years old
  • Malnutrition determined by MNA test (< 17 points)

Exclusion Criteria:

  • If is not possible to perform a nutritional assessment
  • Planned PCI or CABG to correct heart failure etiology
Both
18 Years and older
No
Contact: Juan Luis Bonilla Palomas jnlsbnll@hotmail.com
Spain
 
NCT01472237
PICNIC-2011
Not Provided
Juan Luis Bonilla Palomas, Hospital San Juan de la Cruz
Hospital San Juan de la Cruz
Not Provided
Not Provided
Hospital San Juan de la Cruz
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP