Nutritional Status and Prognosis in Heart Failure.

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01396824

Acronym

PLICA

Enrollment

214

Registered

2011-07-19

Start date

2011-06-30

Completion date

2014-09-30

Last updated

2016-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERNo intervention

No intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
All cause mortality	3 years

Secondary

Measure	Time frame
Cardiac mortality and non-cardiac mortality	3 years
Heart failure hospitalizations	3 years

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026