Nutritional Status and Prognosis in Heart Failure.

Completed

• Conditions: Heart Failure
• Interventions: Other: No intervention

• Registration Number: NCT01396824
• Lead Sponsor: Germans Trias i Pujol Hospital

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 Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-18
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-19
• Primary Completion: 2013-07
• Study Completion: 2014-09
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-01
• Last Update Posted: 2016-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 214

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Heart failure	No intervention	Heart failure patients attending a HF clinic with depressed LVEF (\< 45%) or ≥ 1 hospital admission due to HF decompensation.

Primary Outcome Measures

Name	Time	Method
All cause mortality	3 years

Secondary Outcome Measures

Name	Time	Method
Heart failure hospitalizations	3 years
Cardiac mortality and non-cardiac mortality	3 years

Trial Locations

Locations (1)

Germans Trias Research Institute; Germans Trias University Hospital; 🇪🇸 Badalona, Barcelona, Spain