Strategies for Assessment of Fluid Overload in Acute Decompensated Heart Failure (FLUID-AHF)

March 5, 2024 updated by: Region Skane
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

21

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Helsingborg, Sweden
        • Helsingborg General Hospital
      • Lund, Sweden
        • Skåne University Hospital
      • Malmö, Sweden
        • Skåne University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Decompensated heart failure
Previously diagnosed heart failure presenting with decompensation to the emergency department
Other: Lung ultrasound
Decompensated HF patients will be evaluated at admission and prior to hospital discharge with a range of tools including lung ultrasound imaging
Other: Echocardiography
Comprehensive echocardiography with evaluation of filling pressures
Other: Peripheral venous pressure
Assessment of peripheral venous pressure
Other: Magnetic resonance imaging
Cardiac magnetic resonance imaging
Other: Pulmonary scintigraphy
Assessment of pulmonary perfusion with scintigraphy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rehospitalization/mortality
Time Frame: 2021-2023
Rehospitalization or death within 30 days due to decompensated heart failure
2021-2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Skane

Investigators

  • Study Director: Caroline Heijl, MD, PhD, Cardiology Department, Lund University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2022

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

May 20, 2021

First Submitted That Met QC Criteria

May 20, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-03088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Lung ultrasound

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe