Handheld Ultrasound Evaluation of the Inferior Vena Cava to Guide Heart Failure Treatment

NCT01962688 | Terminated Results

• 2 other identifiers: GCO 13-0324IF1486768
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if using a portable handheld ultrasound to guide diuretic therapy for heart failure patients will prevent hospital readmissions. This study will use a handheld ultrasound called a Vscan to look at a large vessel in the body called the Inferior Vena Cava (a vein leading to your heart) . The study aims to see whether changing diuretic therapy based on the size of this vessel will result in the less hospitalizations for heart failure patients as compared to just symptom guided therapy. This study is composed of two independent non-interacting trials-one in the outpatient setting and one in the inpatient setting.

Conditions

Heart Failure

Keywords

Heart Failure; Handheld ultrasound; Inferior Vena Cava

Outcome Measures

Primary Outcomes (3)

• Number of Participants Hospitalized for Cardiovascular Reasons

  hospitalization information will be recorded throughout the length of the study for the outpatient arms

  up to 6 months

• Number of Participants Hospitalized for Non-cardiac Reasons

  hospitalization information will be recorded throughout the length of the study for the inpatient arms

  up to 6 months

• Diuretic Change Post-visit

  Differences in Changes made in Diuretic doses after Heart failure related visit

  6 months followup

Secondary Outcomes (3)

• Number of Participants in Each New York Heart Association Class

  6 months

• Change in Health Related Quality of Life

  1 month and 6 months

• Length of Stay

  up to 6 months

Study Arms (4)

Handheld ultrasound - inpatient

EXPERIMENTAL

Handheld Ultrasound IVC Diameter Guided Diuretic Therapy Handheld ultrasound of the IVC diameter is used to guide diuretic therapy

Device: Handheld ultrasound

Sham ultrasound - inpatient

SHAM COMPARATOR

Conventional Symptom Guided Diuretic Therapy conventional clinical care as would occur outside of the study. These patients receive a sham ultrasound to facilitate blinding

Device: Sham ultrasound

Handheld ultrasound - ambulatory

EXPERIMENTAL

Handheld Ultrasound IVC Diameter Guided Diuretic Therapy Handheld ultrasound of the IVC diameter is used to guide diuretic therapy in the ambulatory setting during normal clinic visits.

Device: Handheld ultrasound

Sham ultrasound - ambulatory

SHAM COMPARATOR

Conventional Symptom Guided Diuretic Therapy conventional clinical care as would occur outside of the study. These patients receive a sham ultrasound to facilitate blinding in the ambulatory setting during normal clinic visits.

Device: Sham ultrasound

Interventions

Handheld ultrasound DEVICE

Handheld ultrasound determination of IVC diameter

Also known as: VSCAN, Handheld Ultrasound IVC Diameter Guided Diuretic Therapy

Handheld ultrasound - ambulatory; Handheld ultrasound - inpatient

Sham ultrasound DEVICE

sham ultrasound to facilitate blinding

Also known as: Conventional Symptom Guided Diuretic Therapy

Sham ultrasound - ambulatory; Sham ultrasound - inpatient

Eligibility Criteria

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

You may qualify if:

• Patients with a diagnosis of congestive heart failure
• NYHA class II-IV (ambulatory only)
• left ventricular systolic dysfunction with ejection fraction (EF) \< 50%
• history of hospitalization for heart failure within the last year (ambulatory only)
• age \>18 years old
• admission to heart failure service (inpatient arm only)

You may not qualify if:

• Patients with dyspnea not mainly due to heart failure
• valvular disease requiring surgery
• acute coronary syndromes within the previous 10 days
• revascularization within the previous month
• body mass index higher than 35
• serum creatinine level higher than 2.49 mg/dL
• a life expectancy of less than 3 years from noncardiovascular diseases (ambulatory arm only)
• a life expectancy of less than 1 year from noncardiovascular disease (inpatient arm only)
• non-cardiovascular causes of acute renal failure present on admission that preclude the use of diuretics (inpatient arm only)
• unable to give informed consent
• no follow-up possible
• participating in another study

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (25)

• Lloyd-Jones D, Adams RJ, Brown TM, Carnethon M, Dai S, De Simone G, Ferguson TB, Ford E, Furie K, Gillespie C, Go A, Greenlund K, Haase N, Hailpern S, Ho PM, Howard V, Kissela B, Kittner S, Lackland D, Lisabeth L, Marelli A, McDermott MM, Meigs J, Mozaffarian D, Mussolino M, Nichol G, Roger VL, Rosamond W, Sacco R, Sorlie P, Stafford R, Thom T, Wasserthiel-Smoller S, Wong ND, Wylie-Rosett J; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Executive summary: heart disease and stroke statistics--2010 update: a report from the American Heart Association. Circulation. 2010 Feb 23;121(7):948-54. doi: 10.1161/CIRCULATIONAHA.109.192666. No abstract available.

  PMID: 20177011 BACKGROUND

• Solomon SD, Dobson J, Pocock S, Skali H, McMurray JJ, Granger CB, Yusuf S, Swedberg K, Young JB, Michelson EL, Pfeffer MA; Candesartan in Heart failure: Assessment of Reduction in Mortality and morbidity (CHARM) Investigators. Influence of nonfatal hospitalization for heart failure on subsequent mortality in patients with chronic heart failure. Circulation. 2007 Sep 25;116(13):1482-7. doi: 10.1161/CIRCULATIONAHA.107.696906. Epub 2007 Aug 27.

  PMID: 17724259 BACKGROUND

• O'Connor CM, Abraham WT, Albert NM, Clare R, Gattis Stough W, Gheorghiade M, Greenberg BH, Yancy CW, Young JB, Fonarow GC. Predictors of mortality after discharge in patients hospitalized with heart failure: an analysis from the Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF). Am Heart J. 2008 Oct;156(4):662-73. doi: 10.1016/j.ahj.2008.04.030.

  PMID: 18926148 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.

  PMID: 17113398 BACKGROUND

• Drazner MH, Hellkamp AS, Leier CV, Shah MR, Miller LW, Russell SD, Young JB, Califf RM, Nohria A. Value of clinician assessment of hemodynamics in advanced heart failure: the ESCAPE trial. Circ Heart Fail. 2008 Sep;1(3):170-7. doi: 10.1161/CIRCHEARTFAILURE.108.769778.

  PMID: 19675681 BACKGROUND

• Januzzi JL Jr, Camargo CA, Anwaruddin S, Baggish AL, Chen AA, Krauser DG, Tung R, Cameron R, Nagurney JT, Chae CU, Lloyd-Jones DM, Brown DF, Foran-Melanson S, Sluss PM, Lee-Lewandrowski E, Lewandrowski KB. The N-terminal Pro-BNP investigation of dyspnea in the emergency department (PRIDE) study. Am J Cardiol. 2005 Apr 15;95(8):948-54. doi: 10.1016/j.amjcard.2004.12.032.

  PMID: 15820160 BACKGROUND

• Ommen SR, Nishimura RA, Appleton CP, Miller FA, Oh JK, Redfield MM, Tajik AJ. Clinical utility of Doppler echocardiography and tissue Doppler imaging in the estimation of left ventricular filling pressures: A comparative simultaneous Doppler-catheterization study. Circulation. 2000 Oct 10;102(15):1788-94. doi: 10.1161/01.cir.102.15.1788.

  PMID: 11023933 BACKGROUND

• Kircher BJ, Himelman RB, Schiller NB. Noninvasive estimation of right atrial pressure from the inspiratory collapse of the inferior vena cava. Am J Cardiol. 1990 Aug 15;66(4):493-6. doi: 10.1016/0002-9149(90)90711-9.

  PMID: 2386120 BACKGROUND

• Blair JE, Brennan JM, Goonewardena SN, Shah D, Vasaiwala S, Spencer KT. Usefulness of hand-carried ultrasound to predict elevated left ventricular filling pressure. Am J Cardiol. 2009 Jan 15;103(2):246-7. doi: 10.1016/j.amjcard.2008.08.061. Epub 2008 Oct 30.

  PMID: 19121445 BACKGROUND

• Lucas C, Johnson W, Hamilton MA, Fonarow GC, Woo MA, Flavell CM, Creaser JA, Stevenson LW. Freedom from congestion predicts good survival despite previous class IV symptoms of heart failure. Am Heart J. 2000 Dec;140(6):840-7. doi: 10.1067/mhj.2000.110933.

  PMID: 11099986 BACKGROUND

• Gheorghiade M, Follath F, Ponikowski P, Barsuk JH, Blair JE, Cleland JG, Dickstein K, Drazner MH, Fonarow GC, Jaarsma T, Jondeau G, Sendon JL, Mebazaa A, Metra M, Nieminen M, Pang PS, Seferovic P, Stevenson LW, van Veldhuisen DJ, Zannad F, Anker SD, Rhodes A, McMurray JJ, Filippatos G; European Society of Cardiology; European Society of Intensive Care Medicine. Assessing and grading congestion in acute heart failure: a scientific statement from the acute heart failure committee of the heart failure association of the European Society of Cardiology and endorsed by the European Society of Intensive Care Medicine. Eur J Heart Fail. 2010 May;12(5):423-33. doi: 10.1093/eurjhf/hfq045. Epub 2010 Mar 30.

  PMID: 20354029 BACKGROUND

• Goonewardena SN, Blair JE, Manuchehry A, Brennan JM, Keller M, Reeves R, Price A, Spencer KT, Puthumana J, Gheorghiade M. Use of hand carried ultrasound, B-type natriuretic peptide, and clinical assessment in identifying abnormal left ventricular filling pressures in patients referred for right heart catheterization. J Card Fail. 2010 Jan;16(1):69-75. doi: 10.1016/j.cardfail.2009.08.004. Epub 2009 Sep 26.

  PMID: 20123321 BACKGROUND

• Patel AR, Alsheikh-Ali AA, Mukherjee J, Evangelista A, Quraini D, Ordway LJ, Kuvin JT, Denofrio D, Pandian NG. 3D echocardiography to evaluate right atrial pressure in acutely decompensated heart failure correlation with invasive hemodynamics. JACC Cardiovasc Imaging. 2011 Sep;4(9):938-45. doi: 10.1016/j.jcmg.2011.05.006.

  PMID: 21920330 BACKGROUND

• Blehar DJ, Dickman E, Gaspari R. Identification of congestive heart failure via respiratory variation of inferior vena cava diameter. Am J Emerg Med. 2009 Jan;27(1):71-75. doi: 10.1016/j.ajem.2008.01.002.

  PMID: 19041537 BACKGROUND

• Hollerbach S, Schultze K, Muscholl M, Scholmerich J. [Ultrasonography of the inferior vena cava (IVC) in the diagnosis and monitoring of therapy in patients with chronic congestive heart failure]. Dtsch Med Wochenschr. 2001 Feb 9;126(6):129-33. doi: 10.1055/s-2001-11047. German.

  PMID: 11233879 BACKGROUND

• Guiotto G, Masarone M, Paladino F, Ruggiero E, Scott S, Verde S, Schiraldi F. Inferior vena cava collapsibility to guide fluid removal in slow continuous ultrafiltration: a pilot study. Intensive Care Med. 2010 Apr;36(4):692-6. doi: 10.1007/s00134-009-1745-4. Epub 2010 Jan 22.

  PMID: 20094880 BACKGROUND

• Goonewardena SN, Gemignani A, Ronan A, Vasaiwala S, Blair J, Brennan JM, Shah DP, Spencer KT. Comparison of hand-carried ultrasound assessment of the inferior vena cava and N-terminal pro-brain natriuretic peptide for predicting readmission after hospitalization for acute decompensated heart failure. JACC Cardiovasc Imaging. 2008 Sep;1(5):595-601. doi: 10.1016/j.jcmg.2008.06.005.

  PMID: 19356487 BACKGROUND

• Gackowski A, Isnard R, Golmard JL, Pousset F, Carayon A, Montalescot G, Hulot JS, Thomas D, Piwowarska W, Komajda M. Comparison of echocardiography and plasma B-type natriuretic peptide for monitoring the response to treatment in acute heart failure. Eur Heart J. 2004 Oct;25(20):1788-96. doi: 10.1016/j.ehj.2004.07.038.

  PMID: 15474693 BACKGROUND

• Moreno FL, Hagan AD, Holmen JR, Pryor TA, Strickland RD, Castle CH. Evaluation of size and dynamics of the inferior vena cava as an index of right-sided cardiac function. Am J Cardiol. 1984 Feb 1;53(4):579-85. doi: 10.1016/0002-9149(84)90034-1.

  PMID: 6695787 BACKGROUND

• McCullough PA, Nowak RM, McCord J, Hollander JE, Herrmann HC, Steg PG, Duc P, Westheim A, Omland T, Knudsen CW, Storrow AB, Abraham WT, Lamba S, Wu AH, Perez A, Clopton P, Krishnaswamy P, Kazanegra R, Maisel AS. B-type natriuretic peptide and clinical judgment in emergency diagnosis of heart failure: analysis from Breathing Not Properly (BNP) Multinational Study. Circulation. 2002 Jul 23;106(4):416-22. doi: 10.1161/01.cir.0000025242.79963.4c.

  PMID: 12135939 BACKGROUND

• Miller JB, Sen A, Strote SR, Hegg AJ, Farris S, Brackney A, Amponsah D, Mossallam U. Inferior vena cava assessment in the bedside diagnosis of acute heart failure. Am J Emerg Med. 2012 Jun;30(5):778-83. doi: 10.1016/j.ajem.2011.04.008. Epub 2011 Jun 12.

  PMID: 21665408 BACKGROUND

• Brennan JM, Blair JE, Goonewardena S, Ronan A, Shah D, Vasaiwala S, Kirkpatrick JN, Spencer KT. Reappraisal of the use of inferior vena cava for estimating right atrial pressure. J Am Soc Echocardiogr. 2007 Jul;20(7):857-61. doi: 10.1016/j.echo.2007.01.005.

  PMID: 17617312 BACKGROUND

• Wang CS, FitzGerald JM, Schulzer M, Mak E, Ayas NT. Does this dyspneic patient in the emergency department have congestive heart failure? JAMA. 2005 Oct 19;294(15):1944-56. doi: 10.1001/jama.294.15.1944.

  PMID: 16234501 BACKGROUND

• Jardin F, Vieillard-Baron A. Ultrasonographic examination of the venae cavae. Intensive Care Med. 2006 Feb;32(2):203-206. doi: 10.1007/s00134-005-0013-5. Epub 2006 Feb 1. No abstract available.

  PMID: 16450103 BACKGROUND

• Nagueh SF, Kopelen HA, Zoghbi WA. Relation of mean right atrial pressure to echocardiographic and Doppler parameters of right atrial and right ventricular function. Circulation. 1996 Mar 15;93(6):1160-9. doi: 10.1161/01.cir.93.6.1160.

  PMID: 8653837 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

This is a pilot study that involved a small sample size. Because of small sample size, randomization was per visit rather than per patient.

Results Point of Contact

• Title: Dr. Jagat Narula
• Organization: Icahn School of Mediine at Mount Sinai

jagat.narula@mountsinai.org

212-241-4122

Study Officials

• Jagat Narula, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Dean for Global Affairs, Professor Medicine, Cardiology

Study Record Dates

• First Submitted: October 10, 2013
• First Posted: October 14, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 6, 2018
• Results First Posted: June 6, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)