Heart FailureNCT03547076
Handheld Ultrasound at Remote Locations
A study testing Focused ultrasound diagnostics in people with Heart Failure, run by Helse Nord-Trøndelag HF at 1 site in Norway.
Trial summary
Heart failure causes a large patient and financial burden on the health care system. Pocket ultrasound imaging devices are utilized to improve time to correct diagnosis. Telemedicine is used in a variety of medical professions today. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Focused ultrasound diagnostics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteNorway
- Study dates
- 6 Jun 2018to 30 Jun 2020
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients referred to the outpatient clinic at Levanger Hospital for echocardiography due to suspicion of heart failure, which have consented to participate in the study.
- N-terminal pro brain natriuretic peptide (NT-proBNP) ≥125 ng/L or brain natriuretic peptide ≥35 ng/L
Who cannot join
- The patient is not able to consent.
- The patient has know heart failure
- Known result of any of the following cardiac imaging tests (echocardiography, cardiac magnet resonance imaging (MRI), cardiac (not coronary) computed tomography (CT).
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: The Use of Handheld Ultrasound Utilizing Support by Experts or Automatic Analyses for Improved Diagnostics at Remote Locations
Heart failure causes a large patient and financial burden on the health care system. Pocket ultrasound imaging devices are utilized to improve time to correct diagnosis. Telemedicine is used in a variety of medical professions today. A combination of focused handheld ultrasound imaging performed by general practitioners and dedicated nurses in a heart failure population, utilizing telemedicine for support, has not yet been studied. The aim of the study is to evaluate the feasibility, reliability and clinical influence of implementing handheld focused cardiac ultrasound by general practitioners and nurses for diagnostics and health-related expenditure in outpatients referred with suspected heart failure.
Read the detailed description
Handheld focused cardiac ultrasound in diagnosis of suspected heart failure
Diagnostic ultrasound is more frequently used by clinicians in different scenarios. Echocardiography (cardiac ultrasound) is the most frequently method used when diagnosing heart failure (HF), cardiomyopathies, valvular pathology and cardiac tamponade, as well as other diseases affecting the heart, great vessels and pleural cavity. Ideally, the diagnostic workflow should conclude with a correct diagnosis as soon as possible, as this is important for preserving health and quality of life for the patients, as well as for total health care expenditure and the diagnostic workflow logistics.
For the last 6-7 years smaller and cheaper ultrasound scanners have become available. These pocket-sized (or handheld) imaging devices (PSIDs) have allowed for more inexperienced users, at locations outside the dedicated ultrasound laboratories, to perform ultrasound diagnostics. PSIDs fits in the "white coat" pocket and may be brought to the patient, and thus, allowing diagnostic imaging examinations to be performed at the patients' point-of-care. PSIDs from different vendors are available on the market. Large efforts are made in developing dedicated software helping the inexperienced users to maximize the diagnostic gain of including PSIDs in the diagnostic workflow. Experts have launched the PSIDs as the next generation stethoscope.
The cardiac research groups at Levanger Hospital and NTNU (Norway) have recently evaluated the PSID Vscan® from GE Ultrasound in several studies where the PSID has been tested on cardiac patients by different users. The PSID allow for improved diagnostics by both experts, residents, general practitioners (GPs), as well as medical students and dedicated nurses.
In the inpatients setting the population is selected and the prevalence of disease is high. Research has shown that by using the PSIDs the diagnosis was corrected in up to 1 of 5 medical inpatients. With less experienced users the diagnostic impact may be reduced. Studies from outpatient hospital settings have shown that the PSIDs may allow for diagnostic gain both in cardiac and non-cardiac care. Studies evaluating the influence of using PSIDs by GPs or other health care personnel outside the hospitals are scarce. Thus, there is a need for studies evaluating the use of PSIDs or other imaging modalities performed by the GPs in the outpatient setting.
Education
For all inexperienced users, that are non-experts, dedicated training and education is mandatory to optimize gain and minimize misdiagnosis and subsequent imaging procedures. The gain of including PSIDs in the diagnostic workflow largely depends on the population examined. In the latest recommendation from the European Association of Cardiovascular Imaging (EACVI) no specific numbers are given for the training program, neither regarding time nor number of examinations. However, it is stated that "since the competency in FoCUS (Focused Cardiac UltraSound) should be the minimal net result of the training process, the number of required hours/studies might be adjusted for each trainee according to the results of the competency evaluation incorporated into the ongoing training process". The training program should aim to educate the user in the specific use of the PSIDs relevant for the planned scenarios to "ensure that the operators are aware of their own capacity and limitations, given the specific equipment and different situations".
Telemedicine The health care system of today has implemented a variety of technical tools that are based on advanced technological innovations. Such advances usually require highly technical and medical skills of the users, for optimization of the use and outcome of the advances. The advances in information technology, communication bandwidth capacities of both wired and non-wired networks have made the basis for performing the diagnostics at one place and interpret the diagnostic tests at another location. According to the World Health Organization, telemedicine is defined as "the delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities".
Telemedicine has among others been implemented in radiology, where teleradiology is a common and accepted form in the diagnostic process. The methodology was first implemented in clinical scenarios where the need for a physical meeting between the patient and the physician was lower than the need for the specific tests. Traditionally, ultrasound examinations have been performed by highly specialized personnel and interpreted by the specialist more or less real time and at the same location.
User support Technological advances with the invention of easy-to-use, cheap and attainable ultrasound devices has allowed for a broader spectrum of users to implement ultrasound diagnostics. From the health care providers' point of view, this may allow for moving diagnostics to the patients' point-of-care, in contrast to moving the patients to the diagnostic laboratories. To implement ultrasound diagnostics outside the dedicated diagnostics laboratories, education and support of the users is mandatory. Even though inexperienced users easily can be trained to perform ultrasound images with indices, the interpretation of the images of anatomical structures and cardiac function indices requires experience.
The more inexperienced users can be supported in different ways. Beyond the obligatory theoretical support by literature and possibility to discuss findings with experts, there is need for qualitative feedback on the ultrasound recordings. Telemedicine may offer secure transmission of the ultrasound recordings for interpretation by experts and allowing for discussion as well. The outpatient ultrasound recordings may also be included in hospital referrals. In addition, our research group has been involved in development of an algorithm which can automatically interpret ultrasound recordings of the function of the left ventricle. Such software can give quick feedback which may be helpful for training and education of the user, as well its possibility to improve the diagnostic ability of the ultrasound examination performed by the inexperienced user.
Heart failure Heart failure (HF) affects 15 million Europeans; incidence in Norway is 11.000 per year. The prevalence is increasing due to improvements in diagnostics and therapy, not to mention the increased age of the population. Health care expenditure related to management of heart failure is significant, both with respect to the financial costs and patient burden. Thus, early and correct diagnosis is important to improve patient care and reduce the financial burden on the health care system. Heart failure patients often have comorbidities, and hospitalization is common if not optimally monitored and treated. Today approximately 50% of heart failure patients are readmitted within 6 months after hospitalization for decompensated heart failure.
Hyper- and hypovolemia can both lead to decompensated HF and secondary organ failure caused by inadequate perfusion. However, pleural effusion is easy assessable by ultrasound and in a recent study we found that pleural effusion was present in 42% of the patients. Non-cardiologists may have a growing role in diagnostics and follow-up of outpatient HF patients, and adding ultrasound diagnostics to the consultations may improve care.
Telemedicine in follow-up of patients with chronic heart failure The most advanced way of monitoring chronic HF patients by telemedicine is the use of implantable devices for haemodynamic monitoring, where invasive pressures were automatically uploaded from implanted devices through a patient home monitoring system and used to guide treatment. The Remote monitoring has become appealing, and is a potentially cost-effective method of home management and prevention of readmission.
- Conditions
- Heart Failure
- Being tested
- Focused ultrasound diagnostics
- Keywords
- Pocket sized imaging device, Handheld ultrasound device, General practitioner, Nurse, Focused cardiac ultrasound, FoCUS, Telemedicine, Support
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focused ultrasound diagnosticsDiagnostic test
Patients first be examined by nurses using a pocket-sized imaging device. Secondly, by a General Practitioner using the pocket-sized imaging device. Thirdly, reference echocardiography will be performed by cardiologist using a high-end echocardiographic scanner. Only tools (ultrasound equipment and dedicated software) approved for clinical practice will be used.
The focused ultrasound examination includes three standard apical views (4-chamber, 2-chamber and long axis) with and without color Doppler, in addition to recordings from both pleural cavities and the inferior vena cava. The reference imaging includes the same recordings, but in addition all other chambers and valves are assessed (grey scale, color Doppler, pulsed wave and continuous wave Doppler and tissue Doppler).
| Study group | Role | What they receive |
|---|---|---|
| Focused ultrasound diagnostics | Experimental | Intervention: Focused ultrasound Diagnostics
All participants will first be examined twice with handheld ultrasound, With separate examinations performed by general practioners and nurses (random order). Both will utilize automatic analyses of left ventricular function and telemedicine support for best possible diagnosis of heart failure. Subsequently, reference imaging and diagnostics will be performed by experts (cardiologists). Handheld ultrasound examinations will be compared to Reference. Receives: Diagnostic Test: Focused ultrasound diagnostics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical influence of diagnostic ultrasound examinations supported by telemedicine
Clinical influence will be evaluated by the proportion of patients correct evaluated to have or not to have heart failure by the use of handheld ultrasound
Measured: Clinical influence will be tested on day 0 (time of study inclusion)
Secondary outcomes (1)
Feasibility of handheld cardiac ultrasound performed by general practitioners
ReliabiFeasibility, as the proportion of recordings, of cardiac ultrasound images allowing for assessment of left ventricular function by the operator.
Measured: Feasibility will be tested on day 0 (time of study inclusion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start6 Jun 2018
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Not applicable
- Intervention model
- Sequential
- Model description
- The focused Pocket ultrasound examination and evaluation will be performed by a general practitioner. A similar focused ultrasound examination will be performed by a nurse without evaluation by the nurse. The complete echocardiographic examination by a cardiologist, using a state of the art ultrasound machine is considered the gold standard method.
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Nord-Trøndelag HF
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Levanger and Verdal Muncipality
- Responsible party
- Sponsor
- Investigators
- Havard Dalen, MD, PhD, Study chair, Norwegian University of Science and Tehnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03547076
- Sponsor's protocol ID
- LE-2018_GP1
- Status last verified
- Nov 2021
- First submitted
- 24 May 2018
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD share will follow regulations from the institutions.
Publications
Hjorth-Hansen AK, Magelssen MI, Andersen GN, Graven T, Kleinau JO, Landstad B, Lovstakken L, Skjetne K, Mjolstad OC, Dalen H. Real-time automatic quantification of left ventricular function by hand-held ultrasound devices in patients with suspected heart failure: a feasibility study of a diagnostic test with data from general practitioners, nurses and cardiologists. BMJ Open. 2022 Oct 13;12(10):e063793. doi: 10.1136/bmjopen-2022-063793.
PubMed 36229153
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
- The Use of Handheld Ultrasound Utilizing Support by Experts or Automatic Analyses for Improved Diagnostics at Remote Locations
- ClinicalTrials.gov ID
- NCT03547076
- Acronym / sponsor ID
- LE-2018_GP1
- Conditions
- Heart Failure
- Keywords
- Pocket sized imaging device, Handheld ultrasound device, General practitioner, Nurse, Focused cardiac ultrasound, FoCUS, Telemedicine, Support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Helse Nord-Trøndelag HFUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology, Levanger and Verdal Muncipality
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 6 Jun 2018 (actual)
- 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.
Heart failure causes a large patient and financial burden on the health care system. Pocket ultrasound imaging devices are utilized to improve time to correct diagnosis. Telemedicine is used in a variety of medical professions today. A combination of focused handheld ultrasound imaging performed by general practitioners and dedicated nurses in a heart failure population, utilizing telemedicine for support, has not yet been studied. The aim of the study is to evaluate the feasibility, reliability and clinical influence of implementing handheld focused cardiac ultrasound by general practitioners and nurses for diagnostics and health-related expenditure in outpatients referred with suspected heart failure.
Detailed description
Handheld focused cardiac ultrasound in diagnosis of suspected heart failure
Diagnostic ultrasound is more frequently used by clinicians in different scenarios. Echocardiography (cardiac ultrasound) is the most frequently method used when diagnosing heart failure (HF), cardiomyopathies, valvular pathology and cardiac tamponade, as well as other diseases affecting the heart, great vessels and pleural cavity. Ideally, the diagnostic workflow should conclude with a correct diagnosis as soon as possible, as this is important for preserving health and quality of life for the patients, as well as for total health care expenditure and the diagnostic workflow logistics.
For the last 6-7 years smaller and cheaper ultrasound scanners have become available. These pocket-sized (or handheld) imaging devices (PSIDs) have allowed for more inexperienced users, at locations outside the dedicated ultrasound laboratories, to perform ultrasound diagnostics. PSIDs fits in the "white coat" pocket and may be brought to the patient, and thus, allowing diagnostic imaging examinations to be performed at the patients' point-of-care. PSIDs from different vendors are available on the market. Large efforts are made in developing dedicated software helping the inexperienced users to maximize the diagnostic gain of including PSIDs in the diagnostic workflow. Experts have launched the PSIDs as the next generation stethoscope.
The cardiac research groups at Levanger Hospital and NTNU (Norway) have recently evaluated the PSID Vscan® from GE Ultrasound in several studies where the PSID has been tested on cardiac patients by different users. The PSID allow for improved diagnostics by both experts, residents, general practitioners (GPs), as well as medical students and dedicated nurses.
In the inpatients setting the population is selected and the prevalence of disease is high. Research has shown that by using the PSIDs the diagnosis was corrected in up to 1 of 5 medical inpatients. With less experienced users the diagnostic impact may be reduced. Studies from outpatient hospital settings have shown that the PSIDs may allow for diagnostic gain both in cardiac and non-cardiac care. Studies evaluating the influence of using PSIDs by GPs or other health care personnel outside the hospitals are scarce. Thus, there is a need for studies evaluating the use of PSIDs or other imaging modalities performed by the GPs in the outpatient setting.
Education
For all inexperienced users, that are non-experts, dedicated training and education is mandatory to optimize gain and minimize misdiagnosis and subsequent imaging procedures. The gain of including PSIDs in the diagnostic workflow largely depends on the population examined. In the latest recommendation from the European Association of Cardiovascular Imaging (EACVI) no specific numbers are given for the training program, neither regarding time nor number of examinations. However, it is stated that "since the competency in FoCUS (Focused Cardiac UltraSound) should be the minimal net result of the training process, the number of required hours/studies might be adjusted for each trainee according to the results of the competency evaluation incorporated into the ongoing training process". The training program should aim to educate the user in the specific use of the PSIDs relevant for the planned scenarios to "ensure that the operators are aware of their own capacity and limitations, given the specific equipment and different situations".
Telemedicine The health care system of today has implemented a variety of technical tools that are based on advanced technological innovations. Such advances usually require highly technical and medical skills of the users, for optimization of the use and outcome of the advances. The advances in information technology, communication bandwidth capacities of both wired and non-wired networks have made the basis for performing the diagnostics at one place and interpret the diagnostic tests at another location. According to the World Health Organization, telemedicine is defined as "the delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities".
Telemedicine has among others been implemented in radiology, where teleradiology is a common and accepted form in the diagnostic process. The methodology was first implemented in clinical scenarios where the need for a physical meeting between the patient and the physician was lower than the need for the specific tests. Traditionally, ultrasound examinations have been performed by highly specialized personnel and interpreted by the specialist more or less real time and at the same location.
User support Technological advances with the invention of easy-to-use, cheap and attainable ultrasound devices has allowed for a broader spectrum of users to implement ultrasound diagnostics. From the health care providers' point of view, this may allow for moving diagnostics to the patients' point-of-care, in contrast to moving the patients to the diagnostic laboratories. To implement ultrasound diagnostics outside the dedicated diagnostics laboratories, education and support of the users is mandatory. Even though inexperienced users easily can be trained to perform ultrasound images with indices, the interpretation of the images of anatomical structures and cardiac function indices requires experience.
The more inexperienced users can be supported in different ways. Beyond the obligatory theoretical support by literature and possibility to discuss findings with experts, there is need for qualitative feedback on the ultrasound recordings. Telemedicine may offer secure transmission of the ultrasound recordings for interpretation by experts and allowing for discussion as well. The outpatient ultrasound recordings may also be included in hospital referrals. In addition, our research group has been involved in development of an algorithm which can automatically interpret ultrasound recordings of the function of the left ventricle. Such software can give quick feedback which may be helpful for training and education of the user, as well its possibility to improve the diagnostic ability of the ultrasound examination performed by the inexperienced user.
Heart failure Heart failure (HF) affects 15 million Europeans; incidence in Norway is 11.000 per year. The prevalence is increasing due to improvements in diagnostics and therapy, not to mention the increased age of the population. Health care expenditure related to management of heart failure is significant, both with respect to the financial costs and patient burden. Thus, early and correct diagnosis is important to improve patient care and reduce the financial burden on the health care system. Heart failure patients often have comorbidities, and hospitalization is common if not optimally monitored and treated. Today approximately 50% of heart failure patients are readmitted within 6 months after hospitalization for decompensated heart failure.
Hyper- and hypovolemia can both lead to decompensated HF and secondary organ failure caused by inadequate perfusion. However, pleural effusion is easy assessable by ultrasound and in a recent study we found that pleural effusion was present in 42% of the patients. Non-cardiologists may have a growing role in diagnostics and follow-up of outpatient HF patients, and adding ultrasound diagnostics to the consultations may improve care.
Telemedicine in follow-up of patients with chronic heart failure The most advanced way of monitoring chronic HF patients by telemedicine is the use of implantable devices for haemodynamic monitoring, where invasive pressures were automatically uploaded from implanted devices through a patient home monitoring system and used to guide treatment. The Remote monitoring has become appealing, and is a potentially cost-effective method of home management and prevention of readmission.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The focused Pocket ultrasound examination and evaluation will be performed by a general practitioner. A similar focused ultrasound examination will be performed by a nurse without evaluation by the nurse. The complete echocardiographic examination by a cardiologist, using a state of the art ultrasound machine is considered the gold standard method.
| Arm | Type | Receives |
|---|---|---|
| Focused ultrasound diagnostics | Experimental | Diagnostic Test: Focused ultrasound diagnosticsIntervention: Focused ultrasound Diagnostics All participants will first be examined twice with handheld ultrasound, With separate examinations performed by general practioners and nurses (random order). Both will utilize automatic analyses of left ventricular function and telemedicine support for best possible diagnosis of heart failure. Subsequently, reference imaging and diagnostics will be performed by experts (cardiologists). Handheld ultrasound examinations will be compared to Reference. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients referred to the outpatient clinic at Levanger Hospital for echocardiography due to suspicion of heart failure, which have consented to participate in the study.
- N-terminal pro brain natriuretic peptide (NT-proBNP) ≥125 ng/L or brain natriuretic peptide ≥35 ng/L
Key exclusion criteria (3 listed)
- The patient is not able to consent.
- The patient has know heart failure
- Known result of any of the following cardiac imaging tests (echocardiography, cardiac magnet resonance imaging (MRI), cardiac (not coronary) computed tomography (CT).
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 |
|---|---|---|
| Focused ultrasound diagnosticsPatients first be examined by nurses using a pocket-sized imaging device. Secondly, by a General Practitioner using the pocket-sized imaging device. Thirdly, reference echocardiography will be performed by cardiologist using a high-end echocardiographic scanner. Only tools (ultrasound equipment and dedicated software) approved for clinical practice will be used. The focused ultrasound examination includes three standard apical views (4-chamber, 2-chamber and long axis) with and without color Doppler, in addition to recordings from both pleural cavities and the inferior vena cava. The reference imaging includes the same recordings, but in addition all other chambers and valves are assessed (grey scale, color Doppler, pulsed wave and continuous wave Doppler and tissue Doppler). | Diagnostic test | Focused ultrasound diagnostics |
Primary outcome
Clinical influence of diagnostic ultrasound examinations supported by telemedicine
Time frame: Clinical influence will be tested on day 0 (time of study inclusion)
Clinical influence will be evaluated by the proportion of patients correct evaluated to have or not to have heart failure by the use of handheld ultrasound
1 secondary outcome
Feasibility of handheld cardiac ultrasound performed by general practitioners
Time frame: Feasibility will be tested on day 0 (time of study inclusion)
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 36229153Hjorth-Hansen AK, Magelssen MI, Andersen GN, Graven T, Kleinau JO, Landstad B, Lovstakken L, Skjetne K, Mjolstad OC, Dalen H. Real-time automatic quantification of left ventricular function by hand-held ultrasound devices in patients with suspected heart failure: a feasibility study of a diagnostic test with data from general practitioners, nurses and cardiologists. BMJ Open. 2022 Oct 13;12(10):e063793. doi: 10.1136/bmjopen-2022-063793.
- Individual participant dataSharing planned: Undecided. IPD share will follow regulations from the institutions.
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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.
Havard Dalen, MD, PhD study chair
Norwegian University of Science and Tehnology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Focused ultrasound diagnostics 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 2 inclusion and 3 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?
Clinical influence of diagnostic ultrasound examinations supported by telemedicine (time frame: Clinical influence will be tested on day 0 (time of study inclusion)). 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 NCT03547076, which also lists 1 linked publication.
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.