Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Hospital San Juan de la Cruz.
Recruitment status was  Recruiting
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: NA
Last verified: November 2011
History: No changes posted
  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 ]

Estimated Enrollment: 182
Study Start Date: November 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (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

Contacts
Contact: Juan Luis Bonilla Palomas jnlsbnll@hotmail.com

Locations
Spain
Hospital San Juan de la Cruz Recruiting
Úbeda, Jaen, Spain, 23400
Contact: Juan Luis Bonilla Palomas       jnlsbnll@hotmail.com   
Principal Investigator: Juan Luis Bonilla Palomas         
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: November 11, 2011
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Heart Failure
Malnutrition
Nutrition Disorders
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on November 27, 2014