Nutritional Status and Prognosis in Heart Failure. (PLICA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Antoni Bayés Genís, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:
NCT01396824
First received: July 18, 2011
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention
Heart Failure
Other: No intervention

Study Type: Observational
Study Design: 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).

Resource links provided by NLM:


Further study details as provided by Germans Trias i Pujol Hospital:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiac mortality and non-cardiac mortality [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Heart failure hospitalizations [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 225
Study Start Date: June 2011
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396824

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

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
Study First Received: July 18, 2011
Last Updated: November 13, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014