Nutritional Status and Prognosis in Heart Failure.

NCT ID: NCT01396824

Last Updated: 2016-06-02

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

COMPLETED

Total Enrollment

214 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-09-30

Brief Summary

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The purpose of this study is to determine whether nutritional status or body composition influences the prognosis of heart failure patients.

Detailed Description

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Despite obesity is a cardiovascular risk factor, numerous studies have identified a better prognosis in overweight and obese heart failure (HF) patients. This paradox has been named "the obesity paradox". However, this paradox has been criticized because the parameter used to classify obesity, the body mass index (BMI), has several limitations. Obesity is defined as an abnormal or excessive fat accumulation, and BMI does not always reflect real body fat.

What is more, patients with HF can have their body composition altered with hyperhydration or undernourishment. A pilot study proved that BMI does not indicate true nutritional status in HF. Thus, a further assessment of body composition of HF patients, analyzing the nutritional status rather BMI, could shed light on the obesity paradox. The aim of this study was to assess the nutritional status of a cohort of HF patients, its correspondence with BMI, and its significance in terms of survival.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Heart failure

Heart failure patients attending a HF clinic with depressed LVEF (\< 45%) or ≥ 1 hospital admission due to HF decompensation.

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of heart failure according to the European Guidelines of Heart Failure.
* Depressed LVEF (\< 45%) or ≥ 1 hospital admission due to HF decompensation
* Outpatients \> 18 years of age, male or female, capable of giving an informed consent.

Exclusion Criteria

* Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
* Myopathy or other diseases that could cause significant sarcopenia beyond HF.
* Non-controlled hyperthyroidism
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Germans Trias i Pujol Hospital

OTHER

Sponsor Role lead

Responsible Party

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Antoni Bayés Genís

Chief of the Cardiology Service

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Germans Trias Research Institute; Germans Trias University Hospital

Badalona, Barcelona, Spain

Site Status

Countries

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Spain

References

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Lavie CJ, Milani RV, Artham SM, Patel DA, Ventura HO. The obesity paradox, weight loss, and coronary disease. Am J Med. 2009 Dec;122(12):1106-14. doi: 10.1016/j.amjmed.2009.06.006. Epub 2009 Aug 13.

Reference Type BACKGROUND
PMID: 19682667 (View on PubMed)

Curtis JP, Selter JG, Wang Y, Rathore SS, Jovin IS, Jadbabaie F, Kosiborod M, Portnay EL, Sokol SI, Bader F, Krumholz HM. The obesity paradox: body mass index and outcomes in patients with heart failure. Arch Intern Med. 2005 Jan 10;165(1):55-61. doi: 10.1001/archinte.165.1.55.

Reference Type BACKGROUND
PMID: 15642875 (View on PubMed)

Lavie CJ, Milani RV, Ventura HO, Romero-Corral A. Body composition and heart failure prevalence and prognosis: getting to the fat of the matter in the "obesity paradox". Mayo Clin Proc. 2010 Jul;85(7):605-8. doi: 10.4065/mcp.2010.0333. No abstract available.

Reference Type BACKGROUND
PMID: 20592168 (View on PubMed)

Kalantar-Zadeh K, Block G, Horwich T, Fonarow GC. Reverse epidemiology of conventional cardiovascular risk factors in patients with chronic heart failure. J Am Coll Cardiol. 2004 Apr 21;43(8):1439-44. doi: 10.1016/j.jacc.2003.11.039.

Reference Type BACKGROUND
PMID: 15093881 (View on PubMed)

Gassull MA, Cabre E, Vilar L, Alastrue A, Montserrat A. Protein-energy malnutrition: an integral approach and a simple new classification. Hum Nutr Clin Nutr. 1984 Nov;38(6):419-31.

Reference Type BACKGROUND
PMID: 6440876 (View on PubMed)

Gastelurrutia P, Lupon J, Domingo M, Ribas N, Noguero M, Martinez C, Cortes M, Bayes-Genis A. Usefulness of body mass index to characterize nutritional status in patients with heart failure. Am J Cardiol. 2011 Oct 15;108(8):1166-70. doi: 10.1016/j.amjcard.2011.06.020. Epub 2011 Jul 26.

Reference Type BACKGROUND
PMID: 21798500 (View on PubMed)

Other Identifiers

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ICREC-2011-01

Identifier Type: -

Identifier Source: org_study_id

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