Intravascular Volume Expansion to Neuroendocrine-Renal Function Profiles in Chronic Heart Failure
NCT ID: NCT04156854
Last Updated: 2023-02-08
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
NA
15 participants
INTERVENTIONAL
2020-01-30
2022-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Subjects with heart failure
Subjects admitted to the hospital for acute decompensation of chronic systolic heart failure will have a Quantitated Blood Volume Analysis blood test done
Quantitated Blood Volume Analysis
Measurement of total blood volume, composed of red blood cell mass (RBCM) and plasma volume (PV) by administering low dose iodinated I-131 labeled albumin intravenously then taking blood samples at timed increments.
Interventions
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Quantitated Blood Volume Analysis
Measurement of total blood volume, composed of red blood cell mass (RBCM) and plasma volume (PV) by administering low dose iodinated I-131 labeled albumin intravenously then taking blood samples at timed increments.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* New York Hear Association functional class III-IVa with stage C or D Heart Failure with Left Ventricular Ejection Fraction \<50%
* Intended treatment plan with intravenous loop diuretic therapy during hospitalization
Exclusion Criteria
* Having received any investigational drug or device within 30 days prior to entry into the study.
* Clinically unstable patients (e.g. systolic blood pressure \< 90 mmHg, ongoing requirement for vasopressors or mechanical circulatory support, or mechanical ventilation).
* Hospitalization within three months prior to study for hemodialysis or an ongoing requirement for hemodialysis or ultrafiltration.
* Prior organ transplantation or being on a waiting list for organ transplantation
* Presence of cardiac conditions such as clinically significant cardiac valve stenosis, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or primary arterial pulmonary hypertension (Group 1 PAH).
* History of blood pressure \> 190/115 mmHg or unexplained syncope within the past 3 months.
* Symptomatic carotid artery disease, known critical carotid stenosis, or stroke within the past 3 months
* Clinically significant intrinsic renal disease (eGFR \<15 ml/min/1.72m2), renal artery stenosis, or history of fibromuscular dysplasia of the renal arteries
* Baseline hemoglobin \< 8.5 g/dl, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that is five times or more the upper limit of normal or bilirubin three times or more the upper limit of normal
* History of alcohol abuse within the past 6 months.
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Wayne L. Miller, M.D., Ph.D.
Principal Investigator
Principal Investigators
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Wayne Miller, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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References
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Metra M, Dei Cas L, Bristow MR. The pathophysiology of acute heart failure--it is a lot about fluid accumulation. Am Heart J. 2008 Jan;155(1):1-5. doi: 10.1016/j.ahj.2007.10.011. Epub 2007 Nov 26. No abstract available.
Cody RJ, Covit AB, Schaer GL, Laragh JH, Sealey JE, Feldschuh J. Sodium and water balance in chronic congestive heart failure. J Clin Invest. 1986 May;77(5):1441-52. doi: 10.1172/JCI112456.
Gheorghiade M, Filippatos G, De Luca L, Burnett J. Congestion in acute heart failure syndromes: an essential target of evaluation and treatment. Am J Med. 2006 Dec;119(12 Suppl 1):S3-S10. doi: 10.1016/j.amjmed.2006.09.011.
Damman K, Voors AA, Hillege HL, Navis G, Lechat P, van Veldhuisen DJ, Dargie HJ; CIBIS-2 Investigators and Committees. Congestion in chronic systolic heart failure is related to renal dysfunction and increased mortality. Eur J Heart Fail. 2010 Sep;12(9):974-82. doi: 10.1093/eurjhf/hfq118. Epub 2010 Aug 4.
Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Am Coll Cardiol. 2017 Aug 8;70(6):776-803. doi: 10.1016/j.jacc.2017.04.025. Epub 2017 Apr 28. No abstract available.
Stevenson LW, Perloff JK. The limited reliability of physical signs for estimating hemodynamics in chronic heart failure. JAMA. 1989 Feb 10;261(6):884-8.
Miller WL, Mullan BP. Understanding the heterogeneity in volume overload and fluid distribution in decompensated heart failure is key to optimal volume management: role for blood volume quantitation. JACC Heart Fail. 2014 Jun;2(3):298-305. doi: 10.1016/j.jchf.2014.02.007. Epub 2014 Apr 30.
Anand IS, Ferrari R, Kalra GS, Wahi PL, Poole-Wilson PA, Harris PC. Edema of cardiac origin. Studies of body water and sodium, renal function, hemodynamic indexes, and plasma hormones in untreated congestive cardiac failure. Circulation. 1989 Aug;80(2):299-305. doi: 10.1161/01.cir.80.2.299.
Francis GS, Goldsmith SR, Levine TB, Olivari MT, Cohn JN. The neurohumoral axis in congestive heart failure. Ann Intern Med. 1984 Sep;101(3):370-7. doi: 10.7326/0003-4819-101-3-370.
Davila DF, Nunez TJ, Odreman R, de Davila CA. Mechanisms of neurohormonal activation in chronic congestive heart failure: pathophysiology and therapeutic implications. Int J Cardiol. 2005 Jun 8;101(3):343-6. doi: 10.1016/j.ijcard.2004.08.023.
Mentz RJ, Stevens SR, DeVore AD, Lala A, Vader JM, AbouEzzeddine OF, Khazanie P, Redfield MM, Stevenson LW, O'Connor CM, Goldsmith SR, Bart BA, Anstrom KJ, Hernandez AF, Braunwald E, Felker GM. Decongestion strategies and renin-angiotensin-aldosterone system activation in acute heart failure. JACC Heart Fail. 2015 Feb;3(2):97-107. doi: 10.1016/j.jchf.2014.09.003. Epub 2014 Oct 31.
Schrier RW. Body fluid volume regulation in health and disease: a unifying hypothesis. Ann Intern Med. 1990 Jul 15;113(2):155-9. doi: 10.7326/0003-4819-113-2-155.
Androne AS, Hryniewicz K, Hudaihed A, Mancini D, Lamanca J, Katz SD. Relation of unrecognized hypervolemia in chronic heart failure to clinical status, hemodynamics, and patient outcomes. Am J Cardiol. 2004 May 15;93(10):1254-9. doi: 10.1016/j.amjcard.2004.01.070.
Miller WL, Mullan BP. Volume Overload Profiles in Patients With Preserved and Reduced Ejection Fraction Chronic Heart Failure: Are There Differences? A Pilot Study. JACC Heart Fail. 2016 Jun;4(6):453-9. doi: 10.1016/j.jchf.2016.01.005. Epub 2016 Mar 9.
Miller WL, Mullan BP. Peripheral Venous Hemoglobin and Red Blood Cell Mass Mismatch in Volume Overload Systolic Heart Failure: Implications for Patient Management. J Cardiovasc Transl Res. 2015 Oct;8(7):404-10. doi: 10.1007/s12265-015-9650-4. Epub 2015 Sep 8.
Buglioni A, Cannone V, Cataliotti A, Sangaralingham SJ, Heublein DM, Scott CG, Bailey KR, Rodeheffer RJ, Dessi-Fulgheri P, Sarzani R, Burnett JC Jr. Circulating aldosterone and natriuretic peptides in the general community: relationship to cardiorenal and metabolic disease. Hypertension. 2015 Jan;65(1):45-53. doi: 10.1161/HYPERTENSIONAHA.114.03936. Epub 2014 Nov 3.
Gupta D, Georgiopoulou VV, Kalogeropoulos AP, Dunbar SB, Reilly CM, Sands JM, Fonarow GC, Jessup M, Gheorghiade M, Yancy C, Butler J. Dietary sodium intake in heart failure. Circulation. 2012 Jul 24;126(4):479-85. doi: 10.1161/CIRCULATIONAHA.111.062430. No abstract available.
Doukky R, Avery E, Mangla A, Collado FM, Ibrahim Z, Poulin MF, Richardson D, Powell LH. Impact of Dietary Sodium Restriction on Heart Failure Outcomes. JACC Heart Fail. 2016 Jan;4(1):24-35. doi: 10.1016/j.jchf.2015.08.007.
Levey AS, Coresh J, Greene T, Stevens LA, Zhang YL, Hendriksen S, Kusek JW, Van Lente F; Chronic Kidney Disease Epidemiology Collaboration. Using standardized serum creatinine values in the modification of diet in renal disease study equation for estimating glomerular filtration rate. Ann Intern Med. 2006 Aug 15;145(4):247-54. doi: 10.7326/0003-4819-145-4-200608150-00004.
Feldschuh J. Blood volume measurements in hypertensive disease. In: Larah JH, Brenner BM, eds. Hypertension: Pathology, Diagnosis, and Management. NY, Raven Press, 1990.
Feldschuh J, Enson Y. Prediction of the normal blood volume. Relation of blood volume to body habitus. Circulation. 1977 Oct;56(4 Pt 1):605-12. doi: 10.1161/01.cir.56.4.605.
Katz SD. Blood volume assessment in the diagnosis and treatment of chronic heart failure. Am J Med Sci. 2007 Jul;334(1):47-52. doi: 10.1097/MAJ.0b013e3180ca8c41.
Fairbanks VF, Klee GG, Wiseman GA, Hoyer JD, Tefferi A, Petitt RM, Silverstein MN. Measurement of blood volume and red cell mass: re-examination of 51Cr and 125I methods. Blood Cells Mol Dis. 1996;22(2):169-86; discussion 186a-186g. doi: 10.1006/bcmd.1996.0024.
Dworkin HJ, Premo M, Dees S. Comparison of red cell and whole blood volume as performed using both chromium-51-tagged red cells and iodine-125-tagged albumin and using I-131-tagged albumin and extrapolated red cell volume. Am J Med Sci. 2007 Jul;334(1):37-40. doi: 10.1097/MAJ.0b013e3180986276.
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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19-006517
Identifier Type: -
Identifier Source: org_study_id
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