NCT02936050

Brief Summary

The cost related to management of heart failure is significant, both with respect to the financial costs and the suffer of patients. Still as much as 50% of heart failure patients are readmitted within 6 months after hospitalization for decompensated heart failure. Specialized nurses have a growing role in diagnostics and follow-up of outpatient HF patients, and adding ultrasound diagnostics to the nurses consultations may improve care. In heart failure patients the use of ultrasound as a tool for assessing volume status and guidance of diuretic therapy are promising. Aim of the study is to evaluate the feasibility and reliability of echocardiographic acquisitions by heart failure nurses to assess cardiac function indices and assess volume status in outpatient heart failure clinics combined with a telemedicine approach for near real-time interpretation of the recordings by a cardiologist specialized in echocardiography and heart failure at a remote location.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Oct 2016

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 18, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

November 9, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

September 26, 2016

Last Update Submit

November 5, 2021

Conditions

Heart Failure

Keywords

EchocardiographyTelemedicineNursesDecision supporteHealth

Outcome Measures

Primary Outcomes (1)

  • Reliability of diagnostic ultrasound examinations using support by telemedicine

    Reliability (accuracy) will be tested with C-statistics of ultrasound performed by nurses at an outpatient heart failure clinic, with interpretation by telemedicine support of cardiologist compared to Reference imaging by specialists in cardiology

    Reliability will be tested on day 0 (time of study inclusion)

Secondary Outcomes (5)

  • Feasibility of echocardiography performed by nurses with support by telemedicine

    Feasibility will be tested on day 0 (time of study inclusion)

  • Time use of echocardiography performed by nurses with support by telemedicine

    Feasibility will be tested on day 0 (time of study inclusion)

  • Quality of echocardiography performed by nurses with support by telemedicine

    Quality will be tested on day 0 (time of study inclusion)

  • Classification of type of heart failure by echocardiography by nurses with near real-time support by telemedicine

    Classification of type of heart failure by will be tested on day 0 (time of study inclusion)

  • Evaluation of volume status with echocardiography by nurses with near real-time support by telemedicine

    Evaluation of volume status will be tested on day 0 (time of study inclusion)

Study Arms (1)

Intervention

OTHER

Experimental: Addition of diagnostic ultrasound performed by nurses at the outpatient heart failure clinic. Interpretation by specialist per telemedicine. No Control arm

Procedure: Diagnostic ultrasound

Interventions

Diagnostic ultrasoundPROCEDURE

All participants will be examined by diagnostic ultrasound by nurses for the assessment of the Cardiac size and function, and for volumic state. Transmission of the ultrasound recordings by telemedicine and interpretation by specialist in echocardiography and heart failure. All participants will then be examined by reference imaging in specific ultrasound laboratories.

Also known as: Echocardiography
Intervention

Eligibility Criteria

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

You may qualify if:

  • Heart failure patients at the outpatient heart failure clinic at Levanger Hospital, which have consented to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Levanger Hospital

Levanger, 7600, Norway

Location

MeSH Terms

Conditions

Heart Failure

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Havard Dalen, MD, PhD

    Helse Nord-Trøndelag HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2016

First Posted

October 18, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

November 9, 2021

Record last verified: 2021-11

Locations

NO(1)