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

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ClinicalTrials.gov Identifier: NCT01472237
Recruitment Status : Terminated (Randomization was stopped early because a significant beneficial effect of nutritional intervention was found in the interim analysis)
First Posted : November 16, 2011
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):
Juan Luis Bonilla Palomas, Hospital San Juan de la Cruz

November 11, 2011
November 16, 2011
September 22, 2015
March 2012
April 2015   (Final data collection date for primary outcome measure)
Mortality and heart failure hospitalizations [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01472237 on ClinicalTrials.gov Archive Site
Quality of life [ Time Frame: 12 months ]
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 (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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
120
182
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
Sexes Eligible for Study: All
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