Clinical Trial: Enteral Nutrition in Congestive Heart Failure and Cardiac Cachexia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Influence of Enteral Nutrition on Functional Status and Inflammatory Activation in Patients With Congestive Heart Failure and Cardiac Cachexia.

Brief Summary: The purpose of this study was to determine the effects of a high caloric drink on weight and several other clinical markers including quality of life in patients with unintentional weight loss (cachexia) due to chronic heart failure.

Detailed Summary:

Cardiac cachexia has been shown to be powerful independent predictor of mortality in patients with congestive heart failure (CHF). Unlike starvation, cachectic CHF patients present with a decrease of muscles and/or fat tissue. This probably depends, at least in part, on the level of inflammatory activation. Theoretically, it seems clear that nutritional status has to be improved in cardiac cachexia. It has been suggested that inflammatory activation in CHF may be due to endotoxin translocation through the edematous gut wall. Elevated endotoxin levels have been found in patients with acutely decompensated CHF, but these levels normalized with diuretic treatment. This finding may be of utmost importance. From one side it underscores the need for aggressive diuretic treatment to prevent translocation, from another side however, it suggests potential area for enteral treatment. Enteral route of nutrition may be highly beneficial by diminishing bacterial translocation from guts and/or endotoxin transfer, finally resulting in lower inflammatory activation Numerous experimental studies display that enteral feeding reduces bacterial translocation, endotoxin absorption and positively modulates function of local immune tissue.

A search of the literature shows that very little is known about the effectiveness of nutritional support on functional performance in cachectic CHF patients and actually no reports concern the influence of enteral feeding on immune activation of cachectic CHF patients. Recent information of some links existing between leptin, which is increased in CHF, and inflammatory activation in this syndrome speculate on a functional role of leptin in immune activation in CHF. As leptin is one of the most important hormones in the regulation of body energy metabolism, we think it is reasonable to look also into enteral feeding -induced changes of leptin and concomitant
Sponsor: National Heart and Lung Institute

Current Primary Outcome:

  • Weight (kg) [ Time Frame: 18 weeks ]
  • Quality of Life [ Time Frame: 18 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Lean tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA) [ Time Frame: 18 weeks ]
  • Fat tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA) [ Time Frame: 18 weeks ]
  • Serum levels of inflammatory markers including tumor necrosis factor, its soluble receptors 1 and 2, and interleukin-6 [ Time Frame: 18 weeks ]
  • Biochemistry markers including cholesterol, low density lipoprotein, high density lipoprotein [ Time Frame: 18 weeks ]
  • Left ventricular ejection fraction as assessed by echocardiography [ Time Frame: 18 weeks ]
  • Exercise testing using spiroergometry [ Time Frame: 18 weeks ]


Original Secondary Outcome: Same as current

Information By: National Heart and Lung Institute

Dates:
Date Received: April 3, 2008
Date Started: April 2001
Date Completion:
Last Updated: April 3, 2008
Last Verified: April 2008