Clinical trial NCT01396824: Nutritional Status and Prognosis in Heart Failure.
Official title: Nutrition Status and Body Composition in Ambulatory Patients With Heart Failure and Its Prognostic Significance (PLiegues en Insuficiencia Cardiaca-PLICA).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Malnutrition
Undernutrition
Nutrition Assessment
Nutritional Assessment
Nutritional Index
Prognostic Nutritional Index
Prognostic Nutritional Index (PNI)
Nutritional Status
Prognosis
Heart Failure
Cardiovascular Diseases
Body Composition
Body Weights and Measures
Lead sponsor: Germans Trias i Pujol Hospital
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 214
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive heart failure patients attending the HF clinic of a university hospital.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: All cause mortality
timeFrame: 3 years
Secondary outcomes:
measure: Cardiac mortality and non-cardiac mortality
timeFrame: 3 years
measure: Heart failure hospitalizations
timeFrame: 3 years
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Germans Trias Research Institute; Germans Trias University Hospital
state: Barcelona
Study officials:
References:
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.
citation: 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.
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. No abstract available.
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. doi: 10.1016/j.jacc.2003.11.039.
citation: 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.
citation: 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.