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Heart FailureNCT04156854

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

A study testing Quantitated Blood Volume Analysis in people with Heart Failure, run by Mayo Clinic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Quantitated Blood Volume Analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
30 Jan 2020to 19 Dec 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 11Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

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

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
Being tested
Quantitated Blood Volume Analysis
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quantitated Blood Volume AnalysisDiagnostic test

    Also called BVA

    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.

Study groups in NCT04156854
Study groupRoleWhat they receive
Subjects with heart failureExperimentalSubjects admitted to the hospital for acute decompensation of chronic systolic heart failure will have a Quantitated Blood Volume Analysis blood test done
Receives: Diagnostic Test: Quantitated Blood Volume Analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in total blood volume

    Measured in milliliters

    Measured: Baseline, 1 month, 3 month, and 6 month

  2. Change in red blood cell volume

    Measured in milliliters

    Measured: Baseline, 1 month, 3 month, and 6 month

  3. Change in plasma volume

    Measured in milliliters

    Measured: Baseline, 1 month, 3 month, and 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2019
  2. Study start30 Jan 2020
  3. Primary completion19 Dec 2022
  4. Study completion19 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04156854
Sponsor's protocol ID
19-006517
Status last verified
Feb 2023
First submitted
6 Nov 2019
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18082481

  • 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.

    PubMed 3517066

  • 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.

    PubMed 17113398

  • 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.

    PubMed 20685688

  • 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.

    PubMed 28461007

  • 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.

    PubMed 2913385

  • 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.

    PubMed 24952698

  • 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.

    PubMed 2752558

  • 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.

    PubMed 6147109

  • 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.

    PubMed 15907399

  • 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.

    PubMed 25543972

  • 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.

    PubMed 2193561

  • 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.

    PubMed 15135699

  • 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.

    PubMed 26970830

  • 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.

    PubMed 26350222

Questions about this trial

What is this clinical trial studying?

A study testing Quantitated Blood Volume Analysis in people with Heart Failure, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in total blood volume (time frame: Baseline, 1 month, 3 month, and 6 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04156854, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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