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Ultrasound by Nurses in Heart Failure Patients

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ClinicalTrials.gov Identifier: NCT01794715
Recruitment Status : Completed
First Posted : February 20, 2013
Last Update Posted : November 9, 2021
Information provided by (Responsible Party):
Helse Nord-Trøndelag HF

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.

Condition or disease Intervention/treatment Phase
Heart Failure Procedure: Ultrasound examination by nurses Not Applicable

Detailed Description:

Patient inclusion: Outpatient heart failure clinic. Patients are eligible for inclusion if the are referred with heart failure and concent to participate in the study. No other exclusion criteria other than no willing/able to give their concent.

Study population: Approximately 80 patients Intervention: All participants will undergo careful medical history, physical examination and blood tests led by nurses. All patients will be examined twice (by two nurses), one will routinely add ultrasound examination of the pleural space and the inferior vena cava to assess volume state, the other nurse will not perform ultrasound examination. Full cross-over design were nurses do ultrasound examinations at a random matter.

Patients will then be examined by echocardiography by experience cardiologist's echocardiographers. Outcome measures:Change in therapy after routinely performed ultrasound examinations vs controls, detection of volume state when performing ultrasound examinations compared to controls with cardiologist's echocardiographic examination as a gold standard.

Descriptive data of patients before, under and after examinations.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Is Routine Ultrasound Examination Performed by Nurses Useful in Heart Failure Patients at a Outpatient Clinic
Study Start Date : February 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ultrasound performed by nurses
Examinations including ultrasound examinations
Procedure: Ultrasound examination by nurses
Ultrasound examination performed by nurses. Focused examination of the pleural space and inferior vena cava.
Other Name: Ultrasound

Active Comparator: Ultrasound not performed
Examinations not including ultrasound examinations, otherwise active
Procedure: Ultrasound examination by nurses
Ultrasound examination performed by nurses. Focused examination of the pleural space and inferior vena cava.
Other Name: Ultrasound

Primary Outcome Measures :
  1. Treatment effect [ Time Frame: 0 and 30 days and 6 months ]
    Change in treatment after routinely performed ultrasound vs no ultrasound performed.

Secondary Outcome Measures :
  1. Quality of nurse performed ultrasound [ Time Frame: 0 and 30 days and 6 months ]
    Validation of nurse driven ultrasound. Measures of detection of volume state and specific ultrasonographic measurements compared to reference method (cardiologist performer ultrasound).

Other Outcome Measures:
  1. proBNP vs ultrasound [ Time Frame: 0 and 30 days ]
    Study of which variable that best predicts the clinical treatment of the population

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Not able or not willing to concent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01794715

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Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust
Levanger, Norway, 7600
Sponsors and Collaborators
Helse Nord-Trøndelag HF
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Helse Nord-Trøndelag HF
ClinicalTrials.gov Identifier: NCT01794715    
Other Study ID Numbers: LH-2013-1
Spl hjertesvikt ( Other Identifier: Levanger Hospital )
First Posted: February 20, 2013    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021
Keywords provided by Helse Nord-Trøndelag HF:
Heart failure
Nurse led
Outpatient clinic
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases