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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Heart Failure Malnutrition Nutritional Intervention Mortality Other: Nutritional intervention Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Randomized Cotrolled Trial of Nutritional Intervention Program in Malnourished (Mini Nutritional Assessment < 17) Patients Admitted for Heart Failure
Study Start Date : March 2012
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Nutritional intervention
Modification of diet

Placebo Comparator: Care as usual
The patients are referred to their cardiologyst and primary care physicians
Other: Nutritional intervention
Modification of diet




Primary Outcome Measures :
  1. Mortality and heart failure hospitalizations [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01472237


Locations
Spain
Hospital San Juan de la Cruz
Úbeda, Jaen, Spain, 23400
Sponsors and Collaborators
Hospital San Juan de la Cruz