NCT06181968

Brief Summary

A randomized non-blinded study comparing ultrasound-guided therapy with conventional therapy in acute heart failure patients.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2019

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 13, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

1.3 years

First QC Date

December 13, 2023

Last Update Submit

March 5, 2024

Conditions

Keywords

Acute Heart FailureEchocardiographyLung Ultrasound

Outcome Measures

Primary Outcomes (2)

  • Number of patients with re-hospitalization or death

    post-discharge combined endpoint of re-hospitalization for acute heart failure or death due to any cause

    6-months, also 3-months will be analyzed

  • Number of patients with re-hospitalization

    Post-discharge re-hospitalization due to acute heart failure

    6-months, also 3-months will be analyzed

Secondary Outcomes (1)

  • Number of patients with decongestion

    during hospitalization

Study Arms (2)

Treatment arm

ACTIVE COMPARATOR

Congestive therapy will be guided by findings on daily cardiac- and lung ultrasound

Diagnostic Test: Cardiothoracic ultrasound protocol

Control Arm

SHAM COMPARATOR

This arm will have the same ultrasound exams done daily as the treatment arm, but information will not be available for the treating physician for guiding therapy

Diagnostic Test: Cardiothoracic ultrasound protocol

Interventions

Combined echocardiography and lung ultrasound for guiding therapy

Control ArmTreatment arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Multiple bilateral B-lines as a sign of interstitial syndrome on lung ultrasound
  • Elevated natriuretic peptide level
  • Signs of elevated LVEDP on echocardiography
  • Dyspnea at rest or ortophnea

You may not qualify if:

  • eGFR \<25ml/min/1.73m2 or on dialysis
  • Altered mental orientation
  • Intubated
  • Mitral stenosis or previous mitral valve procedure
  • Chronic pulmonary parenchymal disease Pregnancy/breastfeeding
  • Prisoners
  • Patient under involuntary treatment
  • Decision on study participation not made within 6 hours after receiving information regarding the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Only the treating physician on the ward will know which arm the patient belongs to
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled, blinded
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

December 13, 2023

First Posted

December 26, 2023

Study Start

March 13, 2019

Primary Completion

June 30, 2020

Study Completion

November 30, 2020

Last Updated

March 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share