Intravascular Volume Expansion to Neuroendocrine-Renal Function Profiles in Chronic Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quantitated Blood Volume Analysis
Sponsored by
About this trial
This is an interventional basic science trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- 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
- Meeting none of the Exclusion Criteria
Exclusion Criteria:
- 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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subjects with heart failure
Arm Description
Subjects admitted to the hospital for acute decompensation of chronic systolic heart failure will have a Quantitated Blood Volume Analysis blood test done
Outcomes
Primary Outcome Measures
Change in total blood volume
Measured in milliliters
Change in red blood cell volume
Measured in milliliters
Change in plasma volume
Measured in milliliters
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04156854
Brief Title
Intravascular Volume Expansion to Neuroendocrine-Renal Function Profiles in Chronic Heart Failure
Official Title
Pathophysiologic and Outcomes Impact of the Relation of Intravascular Volume Expansion to Neuroendocrine-Renal Function Profiles in Chronic Heart Failure - Pathway to More Individualized Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 30, 2020 (Actual)
Primary Completion Date
December 19, 2022 (Actual)
Study Completion Date
December 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Subjects with heart failure
Arm Type
Experimental
Arm Description
Subjects admitted to the hospital for acute decompensation of chronic systolic heart failure will have a Quantitated Blood Volume Analysis blood test done
Intervention Type
Diagnostic Test
Intervention Name(s)
Quantitated Blood Volume Analysis
Other Intervention Name(s)
BVA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in total blood volume
Description
Measured in milliliters
Time Frame
Baseline, 1 month, 3 month, and 6 month
Title
Change in red blood cell volume
Description
Measured in milliliters
Time Frame
Baseline, 1 month, 3 month, and 6 month
Title
Change in plasma volume
Description
Measured in milliliters
Time Frame
Baseline, 1 month, 3 month, and 6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Meeting none of the Exclusion Criteria
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne Miller, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18082481
Citation
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.
Results Reference
background
PubMed Identifier
3517066
Citation
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.
Results Reference
background
PubMed Identifier
17113398
Citation
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.
Results Reference
background
PubMed Identifier
20685688
Citation
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.
Results Reference
background
PubMed Identifier
28461007
Citation
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.
Results Reference
background
PubMed Identifier
2913385
Citation
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.
Results Reference
background
PubMed Identifier
24952698
Citation
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.
Results Reference
background
PubMed Identifier
2752558
Citation
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.
Results Reference
background
PubMed Identifier
6147109
Citation
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.
Results Reference
background
PubMed Identifier
15907399
Citation
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.
Results Reference
background
PubMed Identifier
25543972
Citation
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.
Results Reference
background
PubMed Identifier
2193561
Citation
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.
Results Reference
background
PubMed Identifier
15135699
Citation
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.
Results Reference
background
PubMed Identifier
26970830
Citation
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.
Results Reference
background
PubMed Identifier
26350222
Citation
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.
Results Reference
background
PubMed Identifier
25368032
Citation
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.
Results Reference
background
PubMed Identifier
22825409
Citation
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.
Results Reference
background
PubMed Identifier
26738949
Citation
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.
Results Reference
background
PubMed Identifier
16908915
Citation
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. Erratum In: Ann Intern Med. 2008 Oct 7;149(7):519. Ann Intern Med. 2021 Apr;174(4):584.
Results Reference
background
Citation
Feldschuh J. Blood volume measurements in hypertensive disease. In: Larah JH, Brenner BM, eds. Hypertension: Pathology, Diagnosis, and Management. NY, Raven Press, 1990.
Results Reference
background
PubMed Identifier
902387
Citation
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.
Results Reference
background
PubMed Identifier
17630592
Citation
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.
Results Reference
background
PubMed Identifier
8931957
Citation
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.
Results Reference
background
PubMed Identifier
17630590
Citation
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.
Results Reference
background
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Intravascular Volume Expansion to Neuroendocrine-Renal Function Profiles in Chronic Heart Failure
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