Enteral Nutrition in Congestive Heart Failure and Cardiac Cachexia
NCT ID: NCT00654719
Last Updated: 2008-04-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
29 participants
INTERVENTIONAL
2001-04-30
2002-02-28
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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NutriDrink
Nutritional supplementation that contains 600 kcal/day: protein content 20 g, carbohydrates 72 g, fat 26 g
NutriDrink
Nutritional supplementation that contains 600 kcal/day: protein content 20 g, carbohydrates 72 g, fat 26 g
Placebo
Placebo
Nutritional supplementation containing only 12 kcal/day
Interventions
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NutriDrink
Nutritional supplementation that contains 600 kcal/day: protein content 20 g, carbohydrates 72 g, fat 26 g
Placebo
Nutritional supplementation containing only 12 kcal/day
Eligibility Criteria
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Inclusion Criteria
* 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
* 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,
18 Years
80 Years
ALL
No
Sponsors
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Nutricia Research Fundation
OTHER
National Heart and Lung Institute
OTHER
Responsible Party
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Nutricia Research Foundation
Locations
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Applied Cachexia Research, Department of Cardiology, Charité Medical School, Campus Virchow-Klinikum
Berlin, , Germany
Silesian Center for Heart Diseases
Zabrze, , Poland
Countries
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References
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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.
Anker 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.
Niebauer 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.
Sax 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.
Kotani 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.
Guihot 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.
Heymsfield 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.
Abel 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.
Otaki 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.
Anker 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.
Zhao 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.
Steele 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.
Anker 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.
Toth 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.
Leyva 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.
Cohn JN, Levine TB, Olivari MT, Garberg V, Lura D, Francis GS, Simon AB, Rector T. Plasma norepinephrine as a guide to prognosis in patients with chronic congestive heart failure. N Engl J Med. 1984 Sep 27;311(13):819-23. doi: 10.1056/NEJM198409273111303.
Joseph J, Gilbert EM. The sympathetic nervous system in chronic heart failure. Prog Cardiovasc Dis. 1998 Jul-Aug;41(1 Suppl 1):9-16. doi: 10.1016/s0033-0620(98)80026-1.
Snitker S, Pratley RE, Nicolson M, Tataranni PA, Ravussin E. Relationship between muscle sympathetic nerve activity and plasma leptin concentration. Obes Res. 1997 Jul;5(4):338-40. doi: 10.1002/j.1550-8528.1997.tb00561.x.
Haynes WG, Morgan DA, Walsh SA, Mark AL, Sivitz WI. Receptor-mediated regional sympathetic nerve activation by leptin. J Clin Invest. 1997 Jul 15;100(2):270-8. doi: 10.1172/JCI119532.
Haynes WG, Sivitz WI, Morgan DA, Walsh SA, Mark AL. Sympathetic and cardiorenal actions of leptin. Hypertension. 1997 Sep;30(3 Pt 2):619-23. doi: 10.1161/01.hyp.30.3.619.
Santos-Alvarez J, Goberna R, Sanchez-Margalet V. Human leptin stimulates proliferation and activation of human circulating monocytes. Cell Immunol. 1999 May 25;194(1):6-11. doi: 10.1006/cimm.1999.1490.
Loffreda S, Yang SQ, Lin HZ, Karp CL, Brengman ML, Wang DJ, Klein AS, Bulkley GB, Bao C, Noble PW, Lane MD, Diehl AM. Leptin regulates proinflammatory immune responses. FASEB J. 1998 Jan;12(1):57-65.
Levy JR, LeGall-Salmon E, Santos M, Pandak WM, Stevens W. Effect of enteral versus parenteral nutrition on leptin gene expression and release into the circulation. Biochem Biophys Res Commun. 1997 Aug 8;237(1):98-102. doi: 10.1006/bbrc.1997.7086.
Paccagnella A, Calo MA, Caenaro G, Salandin V, Jus P, Simini G, Heymsfield SB. Cardiac cachexia: preoperative and postoperative nutrition management. JPEN J Parenter Enteral Nutr. 1994 Sep-Oct;18(5):409-16. doi: 10.1177/0148607194018005409.
Rozentryt P, von Haehling S, Lainscak M, Nowak JU, Kalantar-Zadeh K, Polonski L, Anker SD. The effects of a high-caloric protein-rich oral nutritional supplement in patients with chronic heart failure and cachexia on quality of life, body composition, and inflammation markers: a randomized, double-blind pilot study. J Cachexia Sarcopenia Muscle. 2010 Sep;1(1):35-42. doi: 10.1007/s13539-010-0008-0. Epub 2010 Oct 26.
Other Identifiers
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372/2000
Identifier Type: -
Identifier Source: org_study_id