Clinical trial NCT04901039: Strategies for Assessment of Fluid Overload in Acute Decompensated Heart Failure
Official title: Strategies for Assessment of Fluid Overload in Acute Decompensated Heart Failure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Decompensated Heart Failure
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2021-05-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted with decompensated heart failure from 3 hospitals in southern Sweden.

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.


Eligibility criteria: Inclusion criteria:

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

1. The patient is admitted to the hospital with a primary diagnosis of HF (previous echo mandatory)
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 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)
4. 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:

   1. 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
      * Clinically significant or rapid weight gain thought to be related to fluid retention
   2. Laboratory evidence of new or worsening HF, if obtained within 24 hours of presentation, 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 chronically elevated natriuretic peptides, a significant increase should be noted above baseline.
      * Radiological evidence of pulmonary congestion
      * Non-invasive diagnostic evidence of clinically significant elevated left- or right-sided ventricular filling pressure or low cardiac output. For example, echocardiographic criteria could include: E/e' \> 15 or D-dominant pulmonary venous inflow pattern.
      * Invasive diagnostic evidence with right heart catheterization showing a pulmonary capillary wedge pressure (pulmonary artery occlusion pressure) ≥ 18 mmHg, central venous pressure ≥ 12 mmHg, or a cardiac index \< 2.2 L/min/m2
5. 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, or vasodilator)
   * Mechanical or surgical intervention, including:

     * Mechanical circulatory support (e.g. intra-aortic balloon pump, ventricular assist device, extracorporeal membrane oxygenation, total artificial heart)
     * Mechanical fluid removal (e.g., ultrafiltration, hemofiltration, dialysis)

Exclusion Criteria:

• Acute coronary syndrome, cardiogenic chock

Primary outcomes:
measure: Rehospitalization/mortality
timeFrame: 2021-2023
Secondary outcomes:
Other outcomes:
Locations:
city: Helsingborg
country: Sweden
facility: Helsingborg General Hospital
city: Lund
country: Sweden
facility: Skåne University Hospital
city: Malmö
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Cardiology Department, Lund University
name: Caroline Heijl, MD, PhD
role: STUDY_DIRECTOR
References:
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