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Completed

NCT Number: NCT01396824

Nutritional Status and Prognosis in Heart Failure.

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Germans Trias Research Institute; Germans Trias University Hospital

Badalona, Barcelona, 08916, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

No intervention

Primary outcomes

  1. All cause mortality

    Time frame: 3 years

Secondary outcomes

  1. Cardiac mortality and non-cardiac mortality

    Time frame: 3 years

  2. Heart failure hospitalizations

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Germans Trias i Pujol Hospital

Other

Registry information

Official study title

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

Acronym: PLICA

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Jul 19, 2011
Registry last updated
Jun 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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