Role of USCOM in Adult Patients With Heart Failure

NCT02289508 | Completed

• 1 other identifier: 2014.464
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

Brief Summary

Objective: The Ultrasonic Cardiac Output Monitor (USCOM) is a non-invasive, quantitative method for measuring and monitoring cardiovascular haemodynamic parameters in patients. The aims of this study are:

1. 1.To investigate whether USCOM-derived haemodynamic parameters such as Cardiac output (CO), inotropy and oxygen delivery (DO2) have a role in the diagnosis of patients with a compensated heart failure syndrome (cHFS) or acute decompensated heart failure syndrome (adHFS)
2. 2.To investigate whether USCOM-derived haemodynamic parameters such as CO, inotropy and DO2 correlate with heart failure staging, especially New York Heart Association (NYHA) class and American Heart Association (AHA) stage.
3. 3.To investigate whether USCOM-derived haemodynamic parameters such as velocity time interval (vti), stroke volume (SV), CO, SV index (SVI), CO index (CI), inotropy and DO2 correlate with ejection fraction.
4. 4.To investigate whether USCOM-derived haemodynamic variables may be used as prognostic indicators of 30-day, 6-month and 1-year Major Adverse Cardiac Events (MACE).
5. 5.To evaluate the agreement between hemodynamic measurements obtained using the Ultrasonic Cardiac Output Monitor (USCOM®; USCOM Ltd., Sydney, Australia), and reference standards as determined by 2 Dimensional echocardiography (2D-echo) measurements in groups of haemodynamically stable and unstable adult patients.

Conditions

Acute Decompensated Heart Failure; Congestive Heart Failure Compensated

Keywords

Heart Failure; Hemodynamics; Echocardiography; Diagnostic techniques and procedures; Ultrasonography; USCOM

Outcome Measures

Primary Outcomes (1)

• Difference in mean (SD) inotropy between New York Heart Association (NYHA) stages I, II, III and IV

  Inotropy = (Potential energy + kinetic energy) divided by BSA; measured at aortic and pulmonary window by USCOM; units W/m2

  On Day 1

Secondary Outcomes (5)

• Difference in mean (SD) vti, FTc, SV, SVI, CO, CI, MD, SVR, SVRI, SVV, DO2, DO2I, Inotropy and ejection fraction

  On Day 1

• Difference in mean (SD) vti, FTc, SV, SVI, CO, CI, MD, SVR, SVRI, SVV, DO2, DO2I, Inotropy and AHA stage

  On Day 1

• Agreement between CO and SV measured separately by USCOM and 2D-Echo

  On Day 1

• Number of subjects with and without Major Adverse Cardiac Events (MACE).

  30-days, 6-months and 1-year

• Number of subjects with and without acute decompensated heart failure syndrome (adHFS)

  On Day 1

Study Arms (4)

acute decompensated heart failure

Patients who fulfill Framingham criteria will be classified as acute decompensated heart failure (adHF). For this study we define this as an acute change in symptoms and signs within the previous 24 hours. When symptoms gradually deteriorate between one day and one month, it is described as gradual decompensated heart failure (gdHF). Some patients may have both.

Device: Ultrasonic cardiac output monitor; Device: Echocardiography

compensated heart failure

compensated heart failure (cHF) is defined as the existence of heart failure in the absence of any acute exacerbation but which may either include typical chronic symptoms and signs or may be asymptomatic but with evidence of cardiac dysfunction i.e. a reduced ejection fraction.

Device: Ultrasonic cardiac output monitor; Device: Echocardiography

non-heart failure patients

Non-heart failure patients (nHFp) are a patient control group with suspected heart failure but who after further assessment are found not to meet the criteria. Such patients may subsequently be found to have COPD, anaemia, over transfusion. As the purpose of this study is to assess the potential value of USCOM parameters in the assessment of patients with possible heart failure in the clinical setting, it is important to include patients without heart failure.

Device: Ultrasonic cardiac output monitor; Device: Echocardiography

healthy controls

Healthy controls are subjects with not acute or chronic illness.

Device: Ultrasonic cardiac output monitor

Interventions

Ultrasonic cardiac output monitor DEVICE

An Ultrasonic Cardiac Output Monitor, a non-invasive Doppler ultrasonography, is capable of measuring haemodynamic parameters non-invasively and appears to be simple and rapid to use, portable, relatively inexpensive and has less potential complications compared with the standard technique, pulmonary artery thermodilution (PATD). It has been compared favorably with a wide range of standard techniques, including PATD, with good interobserver reliability. USCOM may help on monitoring HF and suggesting proper treatment in order to reduce the mortality of adHF.

Also known as: USCOM

acute decompensated heart failure; compensated heart failure; healthy controls; non-heart failure patients

Echocardiography DEVICE

2D-echo is a conventional standard-of-care tool for non-invasive hemodynamic assessments in adults. The use of 2D-echo requires highly trained personnel, and assessments may take anywhere between 30-45 minutes. It is used to find out the ejection fraction and to compare the haemodynamic parameters with USCOM in this study.

Also known as: Echo

acute decompensated heart failure; compensated heart failure; non-heart failure patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be screened and recruited from adult patients either scheduled for elective 2D-echo at a cardiology clinic at the Prince of Wales Hospital, or attending the emergency department at the Prince of Wales Hospital.

You may qualify if:

• Age ≥ 18 years, AND
• Written informed consent by patient or nearest relative where appropriate, AND Either
• Referred for echocardiography, OR
• At least one typical symptom and one typical sign consistent with possible heart failure, OR
• Healthy volunteers

You may not qualify if:

• Age \<18 years
• Prior enrollment in study
• Patients with known or suspected pregnancy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Cardiff and Vale University Health Board: collaborator
• University Hospitals, Leicester: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

Related Publications (24)

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• Lam LL, Cameron PA, Schneider HG, Abramson MJ, Muller C, Krum H. Meta-analysis: effect of B-type natriuretic peptide testing on clinical outcomes in patients with acute dyspnea in the emergency setting. Ann Intern Med. 2010 Dec 7;153(11):728-35. doi: 10.7326/0003-4819-153-11-201012070-00006.

  PMID: 21135296 BACKGROUND

• McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Bohm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Kober L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Ronnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A; ESC Committee for Practice Guidelines. ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012 Jul;33(14):1787-847. doi: 10.1093/eurheartj/ehs104. Epub 2012 May 19. No abstract available.

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• Van den Oever HL, Murphy EJ, Christie-Taylor GA. USCOM (Ultrasonic Cardiac Output Monitors) lacks agreement with thermodilution cardiac output and transoesophageal echocardiography valve measurements. Anaesth Intensive Care. 2007 Dec;35(6):903-10. doi: 10.1177/0310057X0703500608.

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Related Links

• Census and Statistics Development, Hong Kong SAR

Biospecimen

Retention: SAMPLES WITH DNA

10ml venous blood will be collected through venipuncture. Blood will be centrifuged, plasma decanted, and stored pending B-type Natriuretic Peptide (BNP) measurements.

MeSH Terms

Conditions

Heart Failure

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Timothy H Rainer, MD FCEM

  Accident & Emergency Medicine Academic Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director & Professor

Study Record Dates

• First Submitted: November 6, 2014
• First Posted: November 13, 2014
• Study Start: November 1, 2014
• Primary Completion: February 6, 2018
• Study Completion: February 6, 2018
• Last Updated: February 7, 2018

Record last verified: 2018-02

Locations

CN (1)