Nutritional Intervention Program in Malnourished Patients Admitted for Heart Failure

Heart Failure Clinical Trial

— PICNIC  

Official title:

Randomized Cotrolled Trial of Nutritional Intervention Program in Malnourished (Mini Nutritional Assessment < 17) Patients Admitted for Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01472237
• Other study ID #: PICNIC-2011
• Status: Terminated
• Phase: Phase 3
• First received: November 11, 2011
• Last updated: September 18, 2015
• Start date: March 2012
• Est. completion date: April 2015

Study information

• Verified date: September 2015
• Source: Hospital San Juan de la Cruz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Heart Failure
• Malnutrition
• Mortality
• Nutritional Intervention

Intervention

Other:
• Nutritional intervention
Modification of diet

Locations

Country	Name	City	State
Spain	Hospital San Juan de la Cruz	Úbeda	Jaen

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Juan de la Cruz

Country where clinical trial is conducted

Spain, 

References & Publications (1)

Bonilla-Palomas JL, Gámez-López AL, Anguita-Sánchez MP, Castillo-Domínguez JC, García-Fuertes D, Crespin-Crespin M, López-Granados A, Suárez 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality and heart failure hospitalizations		12 months	Yes
Secondary	Quality of life		12 months	No