NCT01794715

Brief Summary

Cross-over study aimed to study the diagnostic and clinical impact of routinely adding a pocket-size ultrasound examination to traditional care at a outpatient heart failure clinic.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

4 months

First QC Date

February 13, 2013

Last Update Submit

November 5, 2021

Conditions

Keywords

Heart failureNurse ledOutpatient clinicEchocardiographyPocket-sizeUltrasound

Outcome Measures

Primary Outcomes (1)

  • Treatment effect

    Change in treatment after routinely performed ultrasound vs no ultrasound performed.

    0 and 30 days and 6 months

Secondary Outcomes (1)

  • Quality of nurse performed ultrasound

    0 and 30 days and 6 months

Other Outcomes (1)

  • proBNP vs ultrasound

    0 and 30 days

Study Arms (2)

Ultrasound performed by nurses

EXPERIMENTAL

Examinations including ultrasound examinations

Procedure: Ultrasound examination by nurses

Ultrasound not performed

ACTIVE COMPARATOR

Examinations not including ultrasound examinations, otherwise active

Procedure: Ultrasound examination by nurses

Interventions

Ultrasound examination performed by nurses. Focused examination of the pleural space and inferior vena cava.

Also known as: Ultrasound
Ultrasound not performedUltrasound performed by nurses

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients referred to the outpatient heart failure clinic at the local hospital

You may not qualify if:

  • Not able or not willing to concent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust

Levanger, 7600, Norway

Location

Related Publications (2)

  • Gundersen GH, Norekval TM, Graven T, Haug HH, Skjetne K, Kleinau JO, Gustad LT, Dalen H. Patient-reported outcomes and associations with pleural effusion in outpatients with heart failure: an observational cohort study. BMJ Open. 2017 Mar 20;7(3):e013734. doi: 10.1136/bmjopen-2016-013734.

  • Gundersen GH, Norekval TM, Haug HH, Skjetne K, Kleinau JO, Graven T, Dalen H. Adding point of care ultrasound to assess volume status in heart failure patients in a nurse-led outpatient clinic. A randomised study. Heart. 2016 Jan;102(1):29-34. doi: 10.1136/heartjnl-2015-307798. Epub 2015 Oct 5.

MeSH Terms

Conditions

Heart Failure

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2013

First Posted

February 20, 2013

Study Start

February 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 9, 2021

Record last verified: 2021-11

Locations