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)
Information provided by (Responsible Party):
Juan Luis Bonilla Palomas, Hospital San Juan de la Cruz Identifier:
First received: November 11, 2011
Last updated: September 18, 2015
Last verified: September 2015
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 Intervention Phase
Heart Failure
Nutritional Intervention
Other: Nutritional intervention
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: Randomized Cotrolled Trial of Nutritional Intervention Program in Malnourished (Mini Nutritional Assessment < 17) Patients Admitted for Heart Failure

Resource links provided by NLM:

Further study details as provided by Hospital San Juan de la Cruz:

Primary Outcome Measures:
  • Mortality and heart failure hospitalizations [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: March 2012
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01472237

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

Responsible Party: Juan Luis Bonilla Palomas, Cardiologist, Hospital San Juan de la Cruz Identifier: NCT01472237     History of Changes
Other Study ID Numbers: PICNIC-2011
Study First Received: November 11, 2011
Last Updated: September 18, 2015
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases
Nutrition Disorders processed this record on November 25, 2015