Intravascular Volume Expansion to Neuroendocrine-Renal Function Profiles in Chronic Heart Failure

NCT04156854 | Completed

• 1 other identifier: 19-006517
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are trying learn more about how the heart and blood volume interact in subjects with heart failure and how measuring blood volume may help them develop better ways of treating and managing heart failure patients.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (3)

• Change in total blood volume

  Measured in milliliters

  Baseline, 1 month, 3 month, and 6 month

• Change in red blood cell volume

  Measured in milliliters

  Baseline, 1 month, 3 month, and 6 month

• Change in plasma volume

  Measured in milliliters

  Baseline, 1 month, 3 month, and 6 month

Study Arms (1)

Subjects with heart failure

EXPERIMENTAL

Subjects admitted to the hospital for acute decompensation of chronic systolic heart failure will have a Quantitated Blood Volume Analysis blood test done

Diagnostic Test: Quantitated Blood Volume Analysis

Interventions

Quantitated Blood Volume Analysis DIAGNOSTIC_TEST

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.

Also known as: BVA

Subjects with heart failure

Eligibility Criteria

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

You may qualify if:

• Acute Decompensated Chronic Heart Failure, diagnosed clinically with volume overload by the primary Heart Failure provider or Emergency Department physician and admitted to hospital.
• 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

You may not qualify if:

• Age \< 18 years
• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (24)

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  PMID: 3517066 BACKGROUND

• 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.

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• 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.

  PMID: 20685688 BACKGROUND

• 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.

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• 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.

  PMID: 24952698 BACKGROUND

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  PMID: 2752558 BACKGROUND

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• 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.

  PMID: 15907399 BACKGROUND

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  PMID: 25543972 BACKGROUND

• 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.

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• 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.

  PMID: 15135699 BACKGROUND

• 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.

  PMID: 26970830 BACKGROUND

• 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.

  PMID: 26350222 BACKGROUND

• 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.

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• 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.

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• Feldschuh J. Blood volume measurements in hypertensive disease. In: Larah JH, Brenner BM, eds. Hypertension: Pathology, Diagnosis, and Management. NY, Raven Press, 1990.

  BACKGROUND

• 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.

  PMID: 902387 BACKGROUND

• 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.

  PMID: 17630592 BACKGROUND

• 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.

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• 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.

  PMID: 17630590 BACKGROUND

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Wayne Miller, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: January 30, 2020
• Primary Completion: December 19, 2022
• Study Completion: December 19, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)