Chronic Heart FailurePhase 2NCT00654719
Enteral Nutrition in Congestive Heart Failure and Cardiac Cachexia
A Phase 2 study testing NutriDrink in people with Chronic Heart Failure and Cardiac Cachexia, run by National Heart and Lung Institute at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Heart Failure, Cardiac Cachexia
- What is being tested?
- NutriDrink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2001to Feb 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 14Show fewer
- 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,
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Applied Cachexia Research, Department of Cardiology, Charité Medical School, Campus Virchow-Klinikum
Berlin, 13353
About this study
Official title: The Influence of Enteral Nutrition on Functional Status and Inflammatory Activation in Patients With Congestive Heart Failure and Cardiac Cachexia.
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.
Read the 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.
- Conditions
- Chronic Heart Failure, Cardiac Cachexia
- Being tested
- NutriDrink, Placebo
- Keywords
- Heart failure, cachexia
- Medical subject headings
- Heart Failure, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NutriDrinkDietary supplement
Nutritional supplementation that contains 600 kcal/day: protein content 20 g, carbohydrates 72 g, fat 26 g
PlaceboDietary supplement
Nutritional supplementation containing only 12 kcal/day
| Study group | Role | What they receive |
|---|---|---|
| NutriDrink | Active comparator | Nutritional supplementation that contains 600 kcal/day: protein content 20 g, carbohydrates 72 g, fat 26 g Receives: Dietary Supplement: NutriDrink |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight (kg)
Measured: 18 weeks
Quality of Life
Measured: 18 weeks
Secondary outcomes (6)
Lean tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA)
Measured: 18 weeks
Fat tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA)
Measured: 18 weeks
Serum levels of inflammatory markers including tumor necrosis factor, its soluble receptors 1 and 2, and interleukin-6
Measured: 18 weeks
Biochemistry markers including cholesterol, low density lipoprotein, high density lipoprotein
Measured: 18 weeks
Left ventricular ejection fraction as assessed by echocardiography
Measured: 18 weeks
Exercise testing using spiroergometry
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2008 (estimated)
- Study startApr 2001
- Primary completionFeb 2002
- Study completionFeb 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heart and Lung Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Research Fundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00654719
- Sponsor's protocol ID
- 372/2000
- Status last verified
- Apr 2008
- First submitted
- 3 Apr 2008
- Last updated
- 9 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anker SD, Ponikowski P, Varney S, Chua TP, Clark AL, Webb-Peploe KM, Harrington D, Kox WJ, Poole-Wilson PA, Coats AJ. Wasting as independent risk factor for mortality in chronic heart failure. Lancet. 1997 Apr 12;349(9058):1050-3. doi: 10.1016/S0140-6736(96)07015-8.
PubMed 9107242Anker SD, Ponikowski PP, Clark AL, Leyva F, Rauchhaus M, Kemp M, Teixeira MM, Hellewell PG, Hooper J, Poole-Wilson PA, Coats AJ. Cytokines and neurohormones relating to body composition alterations in the wasting syndrome of chronic heart failure. Eur Heart J. 1999 May;20(9):683-93. doi: 10.1053/euhj.1998.1446.
PubMed 10208789Niebauer J, Volk HD, Kemp M, Dominguez M, Schumann RR, Rauchhaus M, Poole-Wilson PA, Coats AJ, Anker SD. Endotoxin and immune activation in chronic heart failure: a prospective cohort study. Lancet. 1999 May 29;353(9167):1838-42. doi: 10.1016/S0140-6736(98)09286-1.
PubMed 10359409Sax HC, Illig KA, Ryan CK, Hardy DJ. Low-dose enteral feeding is beneficial during total parenteral nutrition. Am J Surg. 1996 Jun;171(6):587-90. doi: 10.1016/s0002-9610(96)00039-6.
PubMed 8678205Kotani J, Usami M, Nomura H, Iso A, Kasahara H, Kuroda Y, Oyanagi H, Saitoh Y. Enteral nutrition prevents bacterial translocation but does not improve survival during acute pancreatitis. Arch Surg. 1999 Mar;134(3):287-92. doi: 10.1001/archsurg.134.3.287.
PubMed 10088570Guihot G, Merle V, Leborgne M, Pivert G, Corriol O, Brousse N, Ricour C, Colomb V. Enteral nutrition modifies gut-associated lymphoid tissue in rat regardless of the molecular form of nitrogen supply. J Pediatr Gastroenterol Nutr. 1997 Feb;24(2):153-61. doi: 10.1097/00005176-199702000-00008.
PubMed 9106101Heymsfield SB, Casper K. Congestive heart failure: clinical management by use of continuous nasoenteric feeding. Am J Clin Nutr. 1989 Sep;50(3):539-44. doi: 10.1093/ajcn/50.3.539.
PubMed 2505606Abel RM, Fischer JE, Buckley MJ, Barnett GO, Austen WG. Malnutrition in cardiac surgical patients. Results of a prospective, randomized evaluation of early postoperative parenteral nutrition. Arch Surg. 1976 Jan;111(1):45-50. doi: 10.1001/archsurg.1976.01360190047008.
PubMed 812456Otaki M. Surgical treatment of patients with cardiac cachexia. An analysis of factors affecting operative mortality. Chest. 1994 May;105(5):1347-51. doi: 10.1378/chest.105.5.1347.
PubMed 8181317Anker SD, Rauchhaus M. Insights into the pathogenesis of chronic heart failure: immune activation and cachexia. Curr Opin Cardiol. 1999 May;14(3):211-6. doi: 10.1097/00001573-199905000-00004.
PubMed 10358792Zhao SP, Zeng LH. Elevated plasma levels of tumor necrosis factor in chronic heart failure with cachexia. Int J Cardiol. 1997 Feb;58(3):257-61. doi: 10.1016/s0167-5273(96)02873-2.
PubMed 9076551Steele IC, Nugent AM, Maguire S, Hoper M, Campbell G, Halliday MI, Nicholls DP. Cytokine profile in chronic cardiac failure. Eur J Clin Invest. 1996 Nov;26(11):1018-22. doi: 10.1046/j.1365-2362.1996.2560587.x.
PubMed 8957209Anker SD, Chua TP, Ponikowski P, Harrington D, Swan JW, Kox WJ, Poole-Wilson PA, Coats AJ. Hormonal changes and catabolic/anabolic imbalance in chronic heart failure and their importance for cardiac cachexia. Circulation. 1997 Jul 15;96(2):526-34. doi: 10.1161/01.cir.96.2.526.
PubMed 9244221Toth MJ, Gottlieb SS, Goran MI, Fisher ML, Poehlman ET. Daily energy expenditure in free-living heart failure patients. Am J Physiol. 1997 Mar;272(3 Pt 1):E469-75. doi: 10.1152/ajpendo.1997.272.3.E469.
PubMed 9124554Leyva F, Anker SD, Egerer K, Stevenson JC, Kox WJ, Coats AJ. Hyperleptinaemia in chronic heart failure. Relationships with insulin. Eur Heart J. 1998 Oct;19(10):1547-51. doi: 10.1053/euhj.1998.1045.
PubMed 9820994
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Enteral Nutrition on Functional Status and Inflammatory Activation in Patients With Congestive Heart Failure and Cardiac Cachexia.
- ClinicalTrials.gov ID
- NCT00654719
- Acronym / sponsor ID
- 372/2000
- Conditions
- Chronic Heart Failure, Cardiac Cachexia
- Keywords
- Heart failure, cachexia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- National Heart and Lung InstituteUniversity, hospital or other
- Collaborators
- Nutricia Research Fundation
- Study start
- Apr 2001
- Primary completion
- Feb 2002 (actual)
- Study completion
- Feb 2002 (actual)
- First posted
- 9 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NutriDrink | Active comparator | Dietary Supplement: NutriDrinkNutritional supplementation that contains 600 kcal/day: protein content 20 g, carbohydrates 72 g, fat 26 g |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%,
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NutriDrinkNutritional supplementation that contains 600 kcal/day: protein content 20 g, carbohydrates 72 g, fat 26 g | Dietary supplement | NutriDrink |
| PlaceboNutritional supplementation containing only 12 kcal/day | Dietary supplement | Placebo |
Primary outcome
Weight (kg)
Time frame: 18 weeks
Quality of Life
Time frame: 18 weeks
6 secondary outcomes
Lean tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA)
Time frame: 18 weeks
Fat tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA)
Time frame: 18 weeks
Serum levels of inflammatory markers including tumor necrosis factor, its soluble receptors 1 and 2, and interleukin-6
Time frame: 18 weeks
Biochemistry markers including cholesterol, low density lipoprotein, high density lipoprotein
Time frame: 18 weeks
Left ventricular ejection fraction as assessed by echocardiography
Time frame: 18 weeks
Exercise testing using spiroergometry
Time frame: 18 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2008.
- Background: PubMed 9107242Anker SD, Ponikowski P, Varney S, Chua TP, Clark AL, Webb-Peploe KM, Harrington D, Kox WJ, Poole-Wilson PA, Coats AJ. Wasting as independent risk factor for mortality in chronic heart failure. Lancet. 1997 Apr 12;349(9058):1050-3. doi: 10.1016/S0140-6736(96)07015-8.
- Background: PubMed 10208789Anker SD, Ponikowski PP, Clark AL, Leyva F, Rauchhaus M, Kemp M, Teixeira MM, Hellewell PG, Hooper J, Poole-Wilson PA, Coats AJ. Cytokines and neurohormones relating to body composition alterations in the wasting syndrome of chronic heart failure. Eur Heart J. 1999 May;20(9):683-93. doi: 10.1053/euhj.1998.1446.
- Background: PubMed 10359409Niebauer J, Volk HD, Kemp M, Dominguez M, Schumann RR, Rauchhaus M, Poole-Wilson PA, Coats AJ, Anker SD. Endotoxin and immune activation in chronic heart failure: a prospective cohort study. Lancet. 1999 May 29;353(9167):1838-42. doi: 10.1016/S0140-6736(98)09286-1.
- Background: PubMed 8678205Sax HC, Illig KA, Ryan CK, Hardy DJ. Low-dose enteral feeding is beneficial during total parenteral nutrition. Am J Surg. 1996 Jun;171(6):587-90. doi: 10.1016/s0002-9610(96)00039-6.
- Background: PubMed 10088570Kotani J, Usami M, Nomura H, Iso A, Kasahara H, Kuroda Y, Oyanagi H, Saitoh Y. Enteral nutrition prevents bacterial translocation but does not improve survival during acute pancreatitis. Arch Surg. 1999 Mar;134(3):287-92. doi: 10.1001/archsurg.134.3.287.
- Background: PubMed 9106101Guihot G, Merle V, Leborgne M, Pivert G, Corriol O, Brousse N, Ricour C, Colomb V. Enteral nutrition modifies gut-associated lymphoid tissue in rat regardless of the molecular form of nitrogen supply. J Pediatr Gastroenterol Nutr. 1997 Feb;24(2):153-61. doi: 10.1097/00005176-199702000-00008.
- Background: PubMed 2505606Heymsfield SB, Casper K. Congestive heart failure: clinical management by use of continuous nasoenteric feeding. Am J Clin Nutr. 1989 Sep;50(3):539-44. doi: 10.1093/ajcn/50.3.539.
- Background: PubMed 812456Abel RM, Fischer JE, Buckley MJ, Barnett GO, Austen WG. Malnutrition in cardiac surgical patients. Results of a prospective, randomized evaluation of early postoperative parenteral nutrition. Arch Surg. 1976 Jan;111(1):45-50. doi: 10.1001/archsurg.1976.01360190047008.
- Background: PubMed 8181317Otaki M. Surgical treatment of patients with cardiac cachexia. An analysis of factors affecting operative mortality. Chest. 1994 May;105(5):1347-51. doi: 10.1378/chest.105.5.1347.
- Background: PubMed 10358792Anker SD, Rauchhaus M. Insights into the pathogenesis of chronic heart failure: immune activation and cachexia. Curr Opin Cardiol. 1999 May;14(3):211-6. doi: 10.1097/00001573-199905000-00004.
- Background: PubMed 9076551Zhao SP, Zeng LH. Elevated plasma levels of tumor necrosis factor in chronic heart failure with cachexia. Int J Cardiol. 1997 Feb;58(3):257-61. doi: 10.1016/s0167-5273(96)02873-2.
- Background: PubMed 8957209Steele IC, Nugent AM, Maguire S, Hoper M, Campbell G, Halliday MI, Nicholls DP. Cytokine profile in chronic cardiac failure. Eur J Clin Invest. 1996 Nov;26(11):1018-22. doi: 10.1046/j.1365-2362.1996.2560587.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NutriDrink in people with Chronic Heart Failure and Cardiac Cachexia, run by National Heart and Lung Institute at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (kg) (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00654719, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2008; AzTrials last refreshed its copy on 7 Nov 2026.