Status:
COMPLETED
Enteral Nutrition in Congestive Heart Failure and Cardiac Cachexia
Lead Sponsor:
National Heart and Lung Institute
Collaborating Sponsors:
Nutricia Research Fundation
Conditions:
Chronic Heart Failure
Cardiac Cachexia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 (cachex...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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,
Key Trial Info
Start Date :
April 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2002
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00654719
Start Date
April 1 2001
End Date
February 1 2002
Last Update
April 9 2008
Active Locations (2)
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1
Applied Cachexia Research, Department of Cardiology, Charité Medical School, Campus Virchow-Klinikum
Berlin, Germany, 13353
2
Silesian Center for Heart Diseases
Zabrze, Poland, 41-800