Clinical trial NCT00654719: Enteral Nutrition in Congestive Heart Failure and Cardiac Cachexia
Official title: The Influence of Enteral Nutrition on Functional Status and Inflammatory Activation in Patients With Congestive Heart Failure and Cardiac Cachexia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Heart Failure
Cardiac Cachexia
Keywords: Heart failure
cachexia
Lead sponsor: National Heart and Lung Institute
Sponsor class: OTHER
Collaborators: name: Nutricia Research Fundation
First posted: 2008-04-09
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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 fluctuations of plasma cytokines.

During the last 12 months we have been using nutritional support in cachectic patients with CHF as an adjunct to standard therapy. We were surprised by a significant functional improvement that we observed in many instances. As most of these patients were subjected to aggressive multi-drug diuretic therapy as well, it was impossible to appreciate the role of enteral nutrition in this respect. We think, these observations are worth verification in more controlled prospective studies.

Eligibility criteria: Inclusion Criteria:

* Signing of informed consent,
* Patient with either gender with actual signs or symptoms of congestive heart failure of any origin with NYHA class no less then III,
* Presence of cardiac cachexia as defined above,
* Duration of symptoms of congestive heart failure of at least 6 months,
* Ejection fraction assessed by echocardiography ≤30%,
* Nutritional support will be offered solely to patients with their pharmacological treatment firmly established for at least 30 days.

Exclusion Criteria:

* Acute decompensation with clinically evident pulmonary or abdominal congestion,
* Any situation (apart from congestive heart failure) that may affect absorption of nutrients from the gut,
* Presence of active gastritis or ulcer,
* Presence of cancer,
* Presence of thyreotoxicosis,
* Type I diabetes mellitus,
* Pancreatic insufficiency,
* Treatment with β-blockers,
* Clinically relevant liver disease with significantly elevated enzymes (ALAT or AspAT or ALP 4 times above normal according to local norms),
* Body mass index \> 25,
* unstable angina pectoris or other acute coronary syndromes within last three months,
* Participation in any other studies,
* Signs of uncooperative attitude,
* Known HIV virus infection,

Primary outcomes:
measure: Weight (kg)
timeFrame: 18 weeks
measure: Quality of Life
timeFrame: 18 weeks
Secondary outcomes:
measure: Lean tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA)
timeFrame: 18 weeks
measure: Fat tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA)
timeFrame: 18 weeks
measure: Serum levels of inflammatory markers including tumor necrosis factor, its soluble receptors 1 and 2, and interleukin-6
timeFrame: 18 weeks
measure: Biochemistry markers including cholesterol, low density lipoprotein, high density lipoprotein
timeFrame: 18 weeks
measure: Left ventricular ejection fraction as assessed by echocardiography
timeFrame: 18 weeks
measure: Exercise testing using spiroergometry
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Applied Cachexia Research, Department of Cardiology, Charité Medical School, Campus Virchow-Klinikum
city: Zabrze
country: Poland
facility: Silesian Center for Heart Diseases
Study officials:
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