Nutritional Intervention Program in Malnourished Patients Admitted for Heart Failure

NCT ID: NCT01472237

Last Updated: 2015-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Failure Malnutrition Nutritional Intervention Mortality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Nutritional intervention

Intervention Type OTHER

Modification of diet

Care as usual

The patients are referred to their cardiologyst and primary care physicians

Group Type PLACEBO_COMPARATOR

Nutritional intervention

Intervention Type OTHER

Modification of diet

Interventions

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Nutritional intervention

Modification of diet

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital San Juan de la Cruz

OTHER

Sponsor Role lead

Responsible Party

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Juan Luis Bonilla Palomas

Cardiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital San Juan de la Cruz

Úbeda, Jaen, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 21652135 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34931696 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28262195 (View on PubMed)

Other Identifiers

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PICNIC-2011

Identifier Type: -

Identifier Source: org_study_id

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