Nutritional Status and Prognosis in Heart Failure. (PLICA)
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|ClinicalTrials.gov Identifier: NCT01396824|
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : June 2, 2016
|Condition or disease||Intervention/treatment|
|Heart Failure||Other: No intervention|
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.
|Study Type :||Observational|
|Actual Enrollment :||214 participants|
|Official Title:||Nutrition Status and Body Composition in Ambulatory Patients With Heart Failure and Its Prognostic Significance (PLiegues en Insuficiencia Cardiaca-PLICA).|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||September 2014|
Heart failure patients attending a HF clinic with depressed LVEF (< 45%) or ≥ 1 hospital admission due to HF decompensation.
Other: No intervention
- All cause mortality [ Time Frame: 3 years ]
- Cardiac mortality and non-cardiac mortality [ Time Frame: 3 years ]
- Heart failure hospitalizations [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396824
|Germans Trias Research Institute; Germans Trias University Hospital|
|Badalona, Barcelona, Spain, 08916|