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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
Sponsor:
Information provided by (Responsible Party):
Antoni Bayés Genís, Germans Trias i Pujol Hospital

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

Condition or disease Intervention/treatment
Heart Failure Other: No intervention

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.


Study Type : Observational
Actual Enrollment : 214 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Heart failure
Heart failure patients attending a HF clinic with depressed LVEF (< 45%) or ≥ 1 hospital admission due to HF decompensation.
Other: No intervention
No intervention




Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Cardiac mortality and non-cardiac mortality [ Time Frame: 3 years ]
  2. Heart failure hospitalizations [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Consecutive heart failure patients attending the HF clinic of a university hospital.
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

Information from the National Library of Medicine

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


Locations
Spain
Germans Trias Research Institute; Germans Trias University Hospital
Badalona, Barcelona, Spain, 08916
Sponsors and Collaborators
Germans Trias i Pujol Hospital

Publications:
Responsible Party: Antoni Bayés Genís, Chief of the Cardiology Service, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier: NCT01396824     History of Changes
Other Study ID Numbers: ICREC-2011-01
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: June 2, 2016
Last Verified: June 2016

Keywords provided by Antoni Bayés Genís, Germans Trias i Pujol Hospital:
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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases