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Assessment of Residual Congestion in Acute Decompensated Heart Failure (VExUS-AHF)

2. juli 2026 oppdatert av: Aarhus University Hospital

DESIGN:

A prospective, multicenter, observational cohort study including 580 patients admitted for acute decompensated heart failure (ADHF).

Ultrasound assessment of congestion (VExUS and LUS) will be performed serially during admission: within 48 hours of admission, at the time diuretic therapy is switched from intravenous to oral, and on the day of discharge. The discharge assessment will serve as the primary predictor.

Treating physicians will be blinded to all ultrasound findings. Patients will be followed for 90 days by telephone follow-up and chart review for the primary endpoint, with extended chart review at one year for selected secondary endpoints.

AIMS:

To determine whether combined ultrasound assessment of venous (VExUS) and pulmonary congestion (LUS) at discharge predicts heart failure readmission and all-cause mortality in patients hospitalized with ADHF.

HYPOTHESIS:

Abnormal VExUS and/or LUS findings at discharge are associated with a higher risk of heart failure readmission and all-cause mortality after 90 days.

Studieoversikt

Status

Rekruttering

Forhold

Studietype

Observasjonsmessig

Registrering (Antatt)

580

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Kristoffer Berg-Hansen, MD, PhD
Telefonnummer: +4560540700
E-post: krisbe@rm.dk

Studiesteder

Danmark
- - Aarhus, Danmark, 8200
    - Rekruttering
    - Aarhus University Hospital - Department of Cardiology
    - Ta kontakt med:
      
      Kristoffer Berg-Hansen, MD, PhD
      
      Telefonnummer: +456054070
      
      E-post: krisbe@rm.dk
  - Copenhagen, Danmark, 2650
    - Har ikke rekruttert ennå
    - Copenhagen University Hospital, Amager and Hvidovre Hospital - Department of Cardiology
    - Ta kontakt med:
      
      Johannes Grand, MD, PhD
      
      E-post: johannes.grand@regionh.dk
  - Roskilde, Danmark, 400
    - Har ikke rekruttert ennå
    - Zealand University Hospital - Department of Cardiology
    - Ta kontakt med:
      
      Martin Frydland, MD, PhD
      
      E-post: mafry@regionsjaelland.dk

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Inclusion criteria Age ≥18 years admitted with ADHF, treated with intravenous loop diuretics (≥40 mg furosemide or an equivalent dose of another loop diuretic) during admission, and able to provide written consent will be eligible for inclusion. Clinical evidence of congestion during admission, indicated by ≥1 of the following: pitting peripheral edema, ascites, elevated jugular venous pressure, or radiologic/ultrasound evidence of pulmonary congestion.

Exclusion criteria Pregnancy, moribund, solitary kidney, or inability to provide written consent

Beskrivelse

Inclusion Criteria:

Adults (≥18 years) admitted with ADHF.
Clinical evidence of congestion during admission, indicated by ≥1 of the following: pitting peripheral edema, ascites, elevated jugular venous pressure, or radiologic/ultrasound evidence of pulmonary congestion.
Treatment with ≥40 mg i.v. furosemide or equivalent dose loop diuretic during admission.

Exclusion Criteria:

Pregnancy
Moribund
Solitary kidney
Inability to provide written consent

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
Patients admitted for acute decompensated heart failure

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Composite of heart failure readmission and all-cause mortality Tidsramme: 90 days	Time-to-event analysis. Endpoints appointed by a blinded adjudication committee. Abnormal VExUS will be defined according to criteria from our ongoing validation study. Abnormal LUS is defined as ≥3 B-lines in ≥2 scanning zones per hemithorax (8-zone method) or ≥15 total B-lines overall.	90 days

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Days alive and out of hospital Tidsramme: Within 90 days and one year after discharge	Days alive and out of any hospital within 90 days and 1 year, indexed to discharge; death counts as 0 days. Computed over the complete fixed window using chart-based ascertainment of vital status and admissions. Patients censored early for reasons other than death (e.g. withdrawal) are handled by censoring or exclusion (not scored 0, since 0 denotes death). Analyzed with rank-based methods given the zero-spike and skew.	Within 90 days and one year after discharge
Individual components of the primary endpoint Tidsramme: 90 days and one year after discharge		90 days and one year after discharge
Association between discharge VExUS and markers of congestion Tidsramme: At discharge	Markers of congestion: Objective markers (jugular venous pressure, peripheral edema, pulmonary rales, and weight change), NT-proBNP, renal function, and echocardiographic measures of cardiac function.	At discharge
Incremental prognostic value of discharge VExUS and LUS beyond standard clinical assessment of congestion for predicting 90-day and one-year heart-failure readmission and all-cause mortality Tidsramme: 90 days and 1 year		90 days and 1 year
Post-discharge diuretic use Tidsramme: 90 days	Defined as the change in loop diuretic dose (furosemide-equivalent) from discharge to 30- and 90-day follow-up, and occurrence of diuretic intensification (dose increase or addition of thiazide-type diuretic) within 90 day	90 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Aarhus University Hospital

Samarbeidspartnere

Zealand University Hospital

Amager Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

15. februar 2026

Primær fullføring (Antatt)

1. juni 2028

Studiet fullført (Antatt)

1. november 2028

Datoer for studieregistrering

Først innsendt

26. juni 2026

Først innsendt som oppfylte QC-kriteriene