Know Cancer

forgot password

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

Phase 2
18 Years
80 Years
Not Enrolling
Chronic Heart Failure, Cardiac Cachexia

Thank you

Trial Information

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

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

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.

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,

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Weight (kg)

Outcome Time Frame:

18 weeks

Safety Issue:



Poland: National Monitoring Centre for Clinical Trials - Ministry of Health

Study ID:




Start Date:

April 2001

Completion Date:

February 2002

Related Keywords:

  • Chronic Heart Failure
  • Cardiac Cachexia
  • Heart failure
  • cachexia
  • Cachexia
  • Heart Failure