Nutrition Status and Body Composition in Ambulatory Patients With Heart Failure and Its Prognostic Significance (PLiegues en Insuficiencia Cardiaca-PLICA).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 214
- Locations
- 1
- Primary Endpoint
- All cause mortality
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Antoni Bayés Genís
Chief of the Cardiology Service
Germans Trias i Pujol Hospital