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
  Purpose
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
Malnutrition
Nutritional Intervention
Mortality
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01472237

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

Publications:
Responsible Party: Juan Luis Bonilla Palomas, Cardiologist, Hospital San Juan de la Cruz
ClinicalTrials.gov 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
Malnutrition
Cardiovascular Diseases
Heart Diseases
Nutrition Disorders

ClinicalTrials.gov processed this record on April 27, 2016