Enteral Nutrition in Congestive Heart Failure and Cardiac Cachexia

This study has been completed.
Sponsor:
Collaborator:
Nutricia Research Fundation
Information provided by:
National Heart and Lung Institute
ClinicalTrials.gov Identifier:
NCT00654719
First received: April 3, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Chronic Heart Failure
Cardiac Cachexia
Dietary Supplement: NutriDrink
Dietary Supplement: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Influence of Enteral Nutrition on Functional Status and Inflammatory Activation in Patients With Congestive Heart Failure and Cardiac Cachexia.

Resource links provided by NLM:


Further study details as provided by National Heart and Lung Institute:

Primary Outcome Measures:
  • Weight (kg) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Lean tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Fat tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Serum levels of inflammatory markers including tumor necrosis factor, its soluble receptors 1 and 2, and interleukin-6 [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Biochemistry markers including cholesterol, low density lipoprotein, high density lipoprotein [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Left ventricular ejection fraction as assessed by echocardiography [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Exercise testing using spiroergometry [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: April 2001
Study Completion Date: February 2002
Primary Completion Date: February 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NutriDrink
Nutritional supplementation that contains 600 kcal/day: protein content 20 g, carbohydrates 72 g, fat 26 g
Dietary Supplement: NutriDrink
Nutritional supplementation that contains 600 kcal/day: protein content 20 g, carbohydrates 72 g, fat 26 g
Placebo Comparator: Placebo Dietary Supplement: Placebo
Nutritional supplementation containing only 12 kcal/day

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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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,
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00654719

Locations
Germany
Applied Cachexia Research, Department of Cardiology, Charité Medical School, Campus Virchow-Klinikum
Berlin, Germany, 13353
Poland
Silesian Center for Heart Diseases
Zabrze, Poland, 41-800
Sponsors and Collaborators
National Heart and Lung Institute
Nutricia Research Fundation
  More Information

Publications:

Responsible Party: Iwona Wójcicka-Bartłomiejczyk, director, Nutricia Research Foundation
ClinicalTrials.gov Identifier: NCT00654719     History of Changes
Other Study ID Numbers: 372/2000
Study First Received: April 3, 2008
Last Updated: April 3, 2008
Health Authority: Poland: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by National Heart and Lung Institute:
Heart failure
cachexia

Additional relevant MeSH terms:
Cachexia
Heart Failure
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014