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

Primary Purpose

Heart Failure, Malnutrition, Nutritional Intervention

Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Nutritional intervention
Sponsored by
Hospital San Juan de la Cruz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital San Juan de la Cruz

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nutritional intervention

Care as usual

Arm Description

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.

The patients are referred to their cardiologyst and primary care physicians

Outcomes

Primary Outcome Measures

Mortality and heart failure hospitalizations

Secondary Outcome Measures

Quality of life

Full Information

First Posted
November 11, 2011
Last Updated
September 18, 2015
Sponsor
Hospital San Juan de la Cruz
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1. Study Identification

Unique Protocol Identification Number
NCT01472237
Brief Title
Nutritional Intervention Program in Malnourished Patients Admitted for Heart Failure
Acronym
PICNIC
Official Title
Randomized Cotrolled Trial of Nutritional Intervention Program in Malnourished (Mini Nutritional Assessment < 17) Patients Admitted for Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Randomization was stopped early because a significant beneficial effect of nutritional intervention was found in the interim analysis
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Juan de la Cruz

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Malnutrition, Nutritional Intervention, Mortality

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nutritional intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Care as usual
Arm Type
Placebo Comparator
Arm Description
The patients are referred to their cardiologyst and primary care physicians
Intervention Type
Other
Intervention Name(s)
Nutritional intervention
Intervention Description
Modification of diet
Primary Outcome Measure Information:
Title
Mortality and heart failure hospitalizations
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Hospital San Juan de la Cruz
City
Úbeda
State/Province
Jaen
ZIP/Postal Code
23400
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
21652135
Citation
Bonilla-Palomas JL, Gamez-Lopez AL, Anguita-Sanchez MP, Castillo-Dominguez JC, Garcia-Fuertes D, Crespin-Crespin M, Lopez-Granados A, Suarez 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.
Results Reference
background
PubMed Identifier
34931696
Citation
Baldwin C, de van der Schueren MA, Kruizenga HM, Weekes CE. Dietary advice with or without oral nutritional supplements for disease-related malnutrition in adults. Cochrane Database Syst Rev. 2021 Dec 21;12(12):CD002008. doi: 10.1002/14651858.CD002008.pub5.
Results Reference
derived
PubMed Identifier
28262195
Citation
Bonilla-Palomas JL, Gamez-Lopez AL, Castillo-Dominguez JC, Moreno-Conde M, Lopez Ibanez MC, Alhambra Exposito R, Ramiro Ortega E, Anguita-Sanchez MP, Villar-Raez A. Nutritional Intervention in Malnourished Hospitalized Patients with Heart Failure. Arch Med Res. 2016 Oct;47(7):535-540. doi: 10.1016/j.arcmed.2016.11.005.
Results Reference
derived

Learn more about this trial

Nutritional Intervention Program in Malnourished Patients Admitted for Heart Failure

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