Nutritional Status and Prognosis in Heart Failure.

Heart Failure Clinical Trial

— PLICA  

Official title:

Nutrition Status and Body Composition in Ambulatory Patients With Heart Failure and Its Prognostic Significance (PLiegues en Insuficiencia Cardiaca-PLICA).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396824
• Other study ID #: ICREC-2011-01
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: June 1, 2016
• Start date: June 2011
• Est. completion date: September 2014

Study information

• Verified date: June 2016
• Source: Germans Trias i Pujol Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: September 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Spain	Germans Trias Research Institute; Germans Trias University Hospital	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. Erratum in: Arch Intern Med. 2008 Mar 24;168(6):567. — View Citation

Gassull MA, Cabré 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. — View Citation

Gastelurrutia P, Lupón 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		3 years	No
Secondary	Cardiac mortality and non-cardiac mortality		3 years	No
Secondary	Heart failure hospitalizations		3 years	No