NCT01472237

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P25-P50 for phase_3 heart-failure

Timeline
Completed

Started Mar 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 11, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

3.1 years

First QC Date

November 11, 2011

Last Update Submit

September 18, 2015

Conditions

Heart FailureMalnutritionNutritional InterventionMortality

Outcome Measures

Primary Outcomes (1)

  • Mortality and heart failure hospitalizations

    12 months

Secondary Outcomes (1)

  • Quality of life

    12 months

Study Arms (2)

Nutritional intervention

ACTIVE COMPARATOR

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

Care as usual

PLACEBO COMPARATOR

The patients are referred to their cardiologyst and primary care physicians

Other: Nutritional intervention

Interventions

Nutritional interventionOTHER

Modification of diet

Care as usualNutritional intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients admitted for heart failure
  • \> 18 years old
  • Malnutrition determined by MNA test (\< 17 points)

You may not qualify if:

  • If is not possible to perform a nutritional assessment
  • Planned PCI or CABG to correct heart failure etiology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital San Juan de la Cruz

Úbeda, Jaen, 23400, Spain

Location

Related Publications (3)

  • 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.

    PMID: 21652135BACKGROUND

  • 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.

    PMID: 34931696DERIVED

  • 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.

    PMID: 28262195DERIVED

MeSH Terms

Conditions

Heart FailureMalnutrition

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

November 11, 2011

First Posted

November 16, 2011

Study Start

March 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

ES(1)