Heart FailureNCT01794715
Ultrasound by Nurses in Heart Failure Patients
A study testing Ultrasound examination by nurses in people with Heart Failure, run by Helse Nord-Trøndelag HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Ultrasound examination by nurses
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2013to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients referred to the outpatient heart failure clinic at the local hospital
Who cannot join
- Not able or not willing to concent
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Medicine, Levanger Hospital, Nord-Trøndelag Health Trust
Levanger, 7600
About this study
Official title: Is Routine Ultrasound Examination Performed by Nurses Useful in Heart Failure Patients at a Outpatient Clinic
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Ultrasound examination by nurses
- Keywords
- Heart failure, Nurse led, Outpatient clinic, Echocardiography, Pocket-size, Ultrasound
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound examination by nursesProcedure or surgery
Also called Ultrasound
Ultrasound examination performed by nurses. Focused examination of the pleural space and inferior vena cava.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound performed by nurses | Experimental | Examinations including ultrasound examinations Receives: Procedure: Ultrasound examination by nurses |
| Ultrasound not performed | Active comparator | Examinations not including ultrasound examinations, otherwise active Receives: Procedure: Ultrasound examination by nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment effect
Change in treatment after routinely performed ultrasound vs no ultrasound performed.
Measured: 0 and 30 days and 6 months
Secondary outcomes (1)
Quality of nurse performed ultrasound
Validation of nurse driven ultrasound. Measures of detection of volume state and specific ultrasonographic measurements compared to reference method (cardiologist performer ultrasound).
Measured: 0 and 30 days and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794715
- Sponsor's protocol ID
- LH-2013-1
- Other IDs
- Spl hjertesvikt
- Status last verified
- Nov 2021
- First submitted
- 13 Feb 2013
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28320791Gundersen 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.
PubMed 26438785
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Routine Ultrasound Examination Performed by Nurses Useful in Heart Failure Patients at a Outpatient Clinic
- ClinicalTrials.gov ID
- NCT01794715
- Acronym / sponsor ID
- LH-2013-1
- Conditions
- Heart Failure
- Keywords
- Heart failure, Nurse led, Outpatient clinic, Echocardiography, Pocket-size, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound performed by nurses | Experimental | Procedure: Ultrasound examination by nursesExaminations including ultrasound examinations |
| Ultrasound not performed | Active comparator | Procedure: Ultrasound examination by nursesExaminations not including ultrasound examinations, otherwise active |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients referred to the outpatient heart failure clinic at the local hospital
Key exclusion criteria (1 listed)
- Not able or not willing to concent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound examination by nursesAlso: UltrasoundUltrasound examination performed by nurses. Focused examination of the pleural space and inferior vena cava. | Procedure or surgery | Ultrasound not performed, Ultrasound performed by nurses |
Primary outcome
Treatment effect
Time frame: 0 and 30 days and 6 months
Change in treatment after routinely performed ultrasound vs no ultrasound performed.
1 secondary outcome
Quality of nurse performed ultrasound
Time frame: 0 and 30 days and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Derived from this study: PubMed 28320791Gundersen 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.
- Derived from this study: PubMed 26438785Gundersen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound examination by nurses in people with Heart Failure, run by Helse Nord-Trøndelag HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment effect (time frame: 0 and 30 days and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01794715, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.