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Clinical Trials/NCT01396824
NCT01396824
Completed
Not Applicable

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

Germans Trias i Pujol Hospital1 site in 1 country214 target enrollmentJune 2011
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Germans Trias i Pujol Hospital
Enrollment
214
Locations
1
Primary Endpoint
All cause mortality
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
September 2014
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Antoni Bayés Genís

Chief of the Cardiology Service

Germans Trias i Pujol Hospital

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

Outcomes

Primary Outcomes

All cause mortality

Time Frame: 3 years

Secondary Outcomes

  • Cardiac mortality and non-cardiac mortality(3 years)
  • Heart failure hospitalizations(3 years)

Study Sites (1)

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