Strategies for Assessment of Fluid Overload in Acute Decompensated Heart Failure

Last updated: March 5, 2024
Sponsor: Region Skane
Overall Status: Terminated

Phase

N/A

Condition

Chest Pain

Congestive Heart Failure

Heart Failure

Treatment

Magnetic resonance imaging

Pulmonary scintigraphy

Peripheral venous pressure

Clinical Study ID

NCT04901039
2020-03088
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria: Hospitalization for decompensated heart failure is defined as an event that meets all ofthe following criteria:

  1. The patient is admitted to the hospital with a primary diagnosis of HF (previous echomandatory)
  2. The patient's length-of-stay in hospital extends for at least 24 hours
  3. 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 nocturnaldyspnea)
  • Decreased exercise tolerance
  • Fatigue
  • Other symptoms of worsened end-organ perfusion or volume overload (as determinedby the medical judgement of the investigator)
  1. The patient has objective evidence of new or worsening HF, consisting of at least twophysical examination findings OR one physical examination finding and at least ONElaboratory criterion, including:
  2. Physical examination findings considered to be due to heart failure, includingnew or worsened:
  • Peripheral edema
  • Increasing abdominal distention or ascites (in the absence of primaryhepatic disease)
  • Pulmonary rales/crackles/crepitations
  • Increased jugular venous pressure and/or hepatojugular reflux
  • S3 gallop
  • Clinically significant or rapid weight gain thought to be related to fluidretention
  1. Laboratory evidence of new or worsening HF, if obtained within 24 hours ofpresentation, including:
  • Increased B-type natriuretic peptide (BNP)/ N-terminal pro-BNP (NT-proBNP)concentrations consistent with decompensation of heart failure (such as BNP > 500 pg/mL or NT-proBNP > 2,000 pg/mL). In patients with chronicallyelevated natriuretic peptides, a significant increase should be noted abovebaseline.
  • Radiological evidence of pulmonary congestion
  • Non-invasive diagnostic evidence of clinically significant elevated left- orright-sided ventricular filling pressure or low cardiac output. For example,echocardiographic criteria could include: E/e' > 15 or D-dominant pulmonaryvenous inflow pattern.
  • Invasive diagnostic evidence with right heart catheterization showing apulmonary capillary wedge pressure (pulmonary artery occlusion pressure) ≥ 18 mmHg, central venous pressure ≥ 12 mmHg, or a cardiac index < 2.2L/min/m2
  1. The patient receives initiation or intensification of treatment specifically for HF,including at least one of the following:
  • Augmentation in oral diuretic therapy
  • Intravenous diuretic or vasoactive agent (e.g., inotrope, vasopressor, orvasodilator)
  • Mechanical or surgical intervention, including:
  • Mechanical circulatory support (e.g. intra-aortic balloon pump, ventricularassist device, extracorporeal membrane oxygenation, total artificial heart)
  • Mechanical fluid removal (e.g., ultrafiltration, hemofiltration, dialysis)

Exclusion

Exclusion Criteria:

• Acute coronary syndrome, cardiogenic chock

Study Design

Total Participants: 21
Treatment Group(s): 5
Primary Treatment: Magnetic resonance imaging
Phase:
Study Start date:
April 14, 2022
Estimated Completion Date:
June 01, 2023

Connect with a study center

  • Helsingborg General Hospital

    Helsingborg,
    Sweden

    Site Not Available

  • Skåne University Hospital

    Lund,
    Sweden

    Site Not Available

  • Skåne University Hospital

    Malmö,
    Sweden

    Site Not Available

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