Strategies for Assessment of Fluid Overload in Acute Decompensated Heart Failure

NCT04901039 | Terminated

• 1 other identifier: 2020-03088
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 3

Brief Summary

Heart failure (HF) is the endstage of all heart disease, characterized by inability of either the left or right heart or both to maintain sufficient output of blood for the demands of the body at normal filling pressures. Patients with HF are often admitted to hospital with decompensation and treated with diuretics. Residual congestion at discharge is associated with increased risk of early rehospitalization and adverse outcomes. However, determination of residual decompensation is complicated and a large number of patients admitted with decompensated heart failure are likely discharged before optimal decongestion has been achieved. Lung ultrasound (LUS) is a promising method to determine residual decompensation with the evaluation of B-lines. In this study our primary aim is to evaluate if LUS together with echocardiographic evaluation of filling pressure according to the European Society of Cardiology (ESC) algorithm performs better than clinical assessment to determine fluid status and risk of early rehospitalization in patients hospitalized for AHF.

Conditions

Heart Failure; Decompensated Heart Failure

Outcome Measures

Primary Outcomes (1)

• Rehospitalization/mortality

  Rehospitalization or death within 30 days due to decompensated heart failure

  2021-2023

Study Arms (1)

Decompensated heart failure

Previously diagnosed heart failure presenting with decompensation to the emergency department

Other: Lung ultrasound; Other: Echocardiography; Other: Peripheral venous pressure; Other: Magnetic resonance imaging; Other: Pulmonary scintigraphy

Interventions

Lung ultrasound OTHER

Decompensated HF patients will be evaluated at admission and prior to hospital discharge with a range of tools including lung ultrasound imaging

Decompensated heart failure

Echocardiography OTHER

Comprehensive echocardiography with evaluation of filling pressures

Decompensated heart failure

Peripheral venous pressure OTHER

Assessment of peripheral venous pressure

Decompensated heart failure

Magnetic resonance imaging OTHER

Cardiac magnetic resonance imaging

Decompensated heart failure

Pulmonary scintigraphy OTHER

Assessment of pulmonary perfusion with scintigraphy

Decompensated heart failure

Eligibility Criteria

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

Study Population

Patients admitted with decompensated heart failure from 3 hospitals in southern Sweden.

You may qualify if:

• Hospitalization for decompensated heart failure is defined as an event that meets all of the following criteria:
• The patient is admitted to the hospital with a primary diagnosis of HF (previous echo mandatory)
• The patient's length-of-stay in hospital extends for at least 24 hours
• The patient exhibits documented new or worsening symptoms due to HF on presentation, including at least ONE of the following:
• Dyspnea (dyspnea with exertion, dyspnea at rest, orthopnea, paroxysmal nocturnal dyspnea)
• Decreased exercise tolerance
• Fatigue
• Other symptoms of worsened end-organ perfusion or volume overload (as determined by the medical judgement of the investigator)
• The patient has objective evidence of new or worsening HF, consisting of at least two physical examination findings OR one physical examination finding and at least ONE laboratory criterion, including:
• Physical examination findings considered to be due to heart failure, including new or worsened:
• Peripheral edema
• Increasing abdominal distention or ascites (in the absence of primary hepatic disease)
• Pulmonary rales/crackles/crepitations
• Increased jugular venous pressure and/or hepatojugular reflux
• S3 gallop

You may not qualify if:

• Acute coronary syndrome, cardiogenic chock

Sponsors & Collaborators

• Region Skane: lead

Study Sites (3)

Helsingborg General Hospital

Helsingborg, Sweden

Location

Skåne University Hospital

Lund, Sweden

Location

Skåne University Hospital

Malmo, Sweden

Location

Related Publications (6)

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; ESC Scientific Document Group. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC)Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

  PMID: 27206819 BACKGROUND

• Mebazaa A, Yilmaz MB, Levy P, Ponikowski P, Peacock WF, Laribi S, Ristic AD, Lambrinou E, Masip J, Riley JP, McDonagh T, Mueller C, deFilippi C, Harjola VP, Thiele H, Piepoli MF, Metra M, Maggioni A, McMurray JJ, Dickstein K, Damman K, Seferovic PM, Ruschitzka F, Leite-Moreira AF, Bellou A, Anker SD, Filippatos G. Recommendations on pre-hospital and early hospital management of acute heart failure: a consensus paper from the Heart Failure Association of the European Society of Cardiology, the European Society of Emergency Medicine and the Society of Academic Emergency Medicine--short version. Eur Heart J. 2015 Aug 7;36(30):1958-66. doi: 10.1093/eurheartj/ehv066. Epub 2015 May 21. No abstract available.

  PMID: 25998514 BACKGROUND

• Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL. 2013 ACCF/AHA guideline for the management of heart failure: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):1810-52. doi: 10.1161/CIR.0b013e31829e8807. Epub 2013 Jun 5. No abstract available.

  PMID: 23741057 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

• Gheorghiade M, Konstam MA, Burnett JC Jr, Grinfeld L, Maggioni AP, Swedberg K, Udelson JE, Zannad F, Cook T, Ouyang J, Zimmer C, Orlandi C; Efficacy of Vasopressin Antagonism in Heart Failure Outcome Study With Tolvaptan (EVEREST) Investigators. Short-term clinical effects of tolvaptan, an oral vasopressin antagonist, in patients hospitalized for heart failure: the EVEREST Clinical Status Trials. JAMA. 2007 Mar 28;297(12):1332-43. doi: 10.1001/jama.297.12.1332. Epub 2007 Mar 25.

  PMID: 17384438 BACKGROUND

• Price S, Platz E, Cullen L, Tavazzi G, Christ M, Cowie MR, Maisel AS, Masip J, Miro O, McMurray JJ, Peacock WF, Martin-Sanchez FJ, Di Somma S, Bueno H, Zeymer U, Mueller C; Acute Heart Failure Study Group of the European Society of Cardiology Acute Cardiovascular Care Association. Expert consensus document: Echocardiography and lung ultrasonography for the assessment and management of acute heart failure. Nat Rev Cardiol. 2017 Jul;14(7):427-440. doi: 10.1038/nrcardio.2017.56. Epub 2017 Apr 27.

  PMID: 28447662 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, urine

MeSH Terms

Conditions

Heart Failure

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Caroline Heijl, MD, PhD

  Cardiology Department, Lund University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 25, 2021
• Study Start: April 14, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)