Enteral Nutrition in Congestive Heart Failure and Cardiac Cachexia

NCT00654719 | Completed Phase 2 DMC

• 1 other identifier: 372/2000
• Study Type: interventional
• Target: 29
• Locations: 2 countries
• Sites: 2

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.

Conditions

Chronic Heart Failure; Cardiac Cachexia

Keywords

Heart failure; cachexia

Outcome Measures

Primary Outcomes (2)

• Weight (kg)

  18 weeks

• Quality of Life

  18 weeks

Secondary Outcomes (6)

• Lean tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA)

  18 weeks

• Fat tissue content, total plus arms and legs separately, as assessed by dual X-ray absorptiometry (DEXA)

  18 weeks

• Serum levels of inflammatory markers including tumor necrosis factor, its soluble receptors 1 and 2, and interleukin-6

  18 weeks

• Biochemistry markers including cholesterol, low density lipoprotein, high density lipoprotein

  18 weeks

• Left ventricular ejection fraction as assessed by echocardiography

  18 weeks

Study Arms (2)

NutriDrink

ACTIVE COMPARATOR

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

Dietary Supplement: NutriDrink

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

NutriDrink DIETARY_SUPPLEMENT

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

NutriDrink

Placebo DIETARY_SUPPLEMENT

Nutritional supplementation containing only 12 kcal/day

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• National Heart and Lung Institute: lead
• Nutricia Research Fundation: collaborator

Study Sites (2)

Applied Cachexia Research, Department of Cardiology, Charité Medical School, Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

Silesian Center for Heart Diseases

Zabrze, 41-800, Poland

Location

Related Publications (25)

• 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.

  PMID: 9107242 BACKGROUND

• 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.

  PMID: 10208789 BACKGROUND

• 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.

  PMID: 10359409 BACKGROUND

• 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.

  PMID: 8678205 BACKGROUND

• 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.

  PMID: 10088570 BACKGROUND

• 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.

  PMID: 9106101 BACKGROUND

• 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.

  PMID: 2505606 BACKGROUND

• 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.

  PMID: 812456 BACKGROUND

• 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.

  PMID: 8181317 BACKGROUND

• 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.

  PMID: 10358792 BACKGROUND

• 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.

  PMID: 9076551 BACKGROUND

• 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.

  PMID: 8957209 BACKGROUND

• 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.

  PMID: 9244221 BACKGROUND

• 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.

  PMID: 9124554 BACKGROUND

• 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.

  PMID: 9820994 BACKGROUND

• 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.

  PMID: 6382011 BACKGROUND

• 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.

  PMID: 9715818 BACKGROUND

• 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.

  PMID: 9285841 BACKGROUND

• 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.

  PMID: 9218503 BACKGROUND

• 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.

  PMID: 9322991 BACKGROUND

• 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.

  PMID: 10357875 BACKGROUND

• 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.

  PMID: 9438411 BACKGROUND

• 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.

  PMID: 9266837 BACKGROUND

• 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.

  PMID: 7815671 BACKGROUND

• 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.

  PMID: 21475692 DERIVED

MeSH Terms

Conditions

Heart Failure; Cachexia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 3, 2008
• First Posted: April 9, 2008
• Study Start: April 1, 2001
• Primary Completion: February 1, 2002
• Study Completion: February 1, 2002
• Last Updated: April 9, 2008

Record last verified: 2008-04

Locations

DE (1); PL (1)