AzTrials
AzTrials

Heart FailureFLUID-AHFNCT04901039

Strategies for Assessment of Fluid Overload in Acute Decompensated Heart Failure

An observational study of Heart Failure and Decompensated Heart Failure, run by Region Skane at 3 sites in Sweden.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure, Decompensated Heart Failure
What is being tested?
Lung ultrasound, Echocardiography and Peripheral venous pressure
How many people
21 participants
Where
3 sitesSweden
Study dates
14 Apr 2022to 1 Jun 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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
Show all 27Show fewer
  • 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
  • Clinically significant or rapid weight gain thought to be related to fluid retention
  • 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
  • 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)

Who cannot join

  • Acute coronary syndrome, cardiogenic chock

Trial locations and contacts

3 sites in 1 country.

Sweden3 sites

  • Helsingborg General Hospital

    Helsingborg

  • Skåne University Hospital

    Lund

  • Skåne University Hospital

    Malmö

Other trials in Sweden

About this study

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.

Being tested
Lung ultrasound, Echocardiography, Peripheral venous pressure, Magnetic resonance imaging, Pulmonary scintigraphy
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lung ultrasoundOther

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

  • EchocardiographyOther

    Comprehensive echocardiography with evaluation of filling pressures

  • Peripheral venous pressureOther

    Assessment of peripheral venous pressure

  • Magnetic resonance imagingOther

    Cardiac magnetic resonance imaging

  • Pulmonary scintigraphyOther

    Assessment of pulmonary perfusion with scintigraphy

Study groups in NCT04901039
Study groupRoleWhat they receive
Decompensated heart failurePreviously diagnosed heart failure presenting with decompensation to the emergency department
Receives: Other: Lung ultrasound; Other: Echocardiography; Other: Peripheral venous pressure; Other: Magnetic resonance imaging; Other: Pulmonary scintigraphy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rehospitalization/mortality

    Rehospitalization or death within 30 days due to decompensated heart failure

    Measured: 2021-2023

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2021
  2. Study start14 Apr 2022
  3. Primary completion1 Jun 2023
  4. Study completion1 Jun 2023

Why it stopped: Lack of resources

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04901039
Sponsor's protocol ID
2020-03088
Acronym
FLUID-AHF
Status last verified
Mar 2024
First submitted
20 May 2021
Last updated
7 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27206819

  • 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.

    PubMed 25998514

  • 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.

    PubMed 23741057

  • 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.

    PubMed 20354029

  • 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.

    PubMed 17384438

  • 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.

    PubMed 28447662

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and Decompensated Heart Failure, run by Region Skane at 3 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Lack of resources). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rehospitalization/mortality (time frame: 2021-2023). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04901039, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in