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Enteral Nutrition in Congestive Heart Failure and Cardiac Cachexia

Primary Purpose

Chronic Heart Failure, Cardiac Cachexia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NutriDrink
Placebo
Sponsored by
National Heart and Lung Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring Heart failure, cachexia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Applied Cachexia Research, Department of Cardiology, Charité Medical School, Campus Virchow-Klinikum
  • Silesian Center for Heart Diseases

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NutriDrink

Placebo

Arm Description

Nutritional supplementation that contains 600 kcal/day: protein content 20 g, carbohydrates 72 g, fat 26 g

Outcomes

Primary Outcome Measures

Weight (kg)
Quality of Life

Secondary Outcome Measures

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

Full Information

First Posted
April 3, 2008
Last Updated
April 3, 2008
Sponsor
National Heart and Lung Institute
Collaborators
Nutricia Research Fundation
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1. Study Identification

Unique Protocol Identification Number
NCT00654719
Brief Title
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

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
February 2002 (Actual)
Study Completion Date
February 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart and Lung Institute
Collaborators
Nutricia Research Fundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure, Cardiac Cachexia
Keywords
Heart failure, cachexia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NutriDrink
Arm Type
Active Comparator
Arm Description
Nutritional supplementation that contains 600 kcal/day: protein content 20 g, carbohydrates 72 g, fat 26 g
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
NutriDrink
Intervention Description
Nutritional supplementation that contains 600 kcal/day: protein content 20 g, carbohydrates 72 g, fat 26 g
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Nutritional supplementation containing only 12 kcal/day
Primary Outcome Measure Information:
Title
Weight (kg)
Time Frame
18 weeks
Title
Quality of Life
Time Frame
18 weeks
Secondary Outcome Measure Information:
Title
Lean tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA)
Time Frame
18 weeks
Title
Fat tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA)
Time Frame
18 weeks
Title
Serum levels of inflammatory markers including tumor necrosis factor, its soluble receptors 1 and 2, and interleukin-6
Time Frame
18 weeks
Title
Biochemistry markers including cholesterol, low density lipoprotein, high density lipoprotein
Time Frame
18 weeks
Title
Left ventricular ejection fraction as assessed by echocardiography
Time Frame
18 weeks
Title
Exercise testing using spiroergometry
Time Frame
18 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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,
Facility Information:
Facility Name
Applied Cachexia Research, Department of Cardiology, Charité Medical School, Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Silesian Center for Heart Diseases
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland

12. IPD Sharing Statement

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Enteral Nutrition in Congestive Heart Failure and Cardiac Cachexia

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