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

This study has been terminated.
(Randomization was stopped early because a significant beneficial effect of nutritional intervention was found in the interim analysis)
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: September 18, 2015
Last verified: September 2015

November 11, 2011
September 18, 2015
March 2012
April 2015   (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
Complete list of historical versions of study NCT01472237 on ClinicalTrials.gov Archive Site
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. doi: 10.1016/j.recesp.2011.03.009. 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.
 
Terminated
120
April 2015
April 2015   (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   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01472237
PICNIC-2011
Not Provided
Not Provided
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
September 2015

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