HealthyNCT03436030
Atrial and Ventricular Wall Stress During Breathing
A study testing Simple breathing manuevers during brief echocardiographic imaging in people with Healthy, run by Umeå University at 1 site in Sweden.
Trial summary
Healthy reclining adult volunteers, with Valsalva manoeuver, Muller manoeuver, light continuous positive airway pressure by mask, passive leg raising, and maximal hand-grip. Ultrasound heart images captured before and during. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Simple breathing manuevers during brief echocardiographic imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 18 Nov 2017to 30 Apr 2018
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy adults
Who cannot join
- known heart or lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Atrial and Ventricular Wall Stress, Effects of Breathing and Airway Pressure
Healthy reclining adult volunteers, with Valsalva manoeuver, Muller manoeuver, light continuous positive airway pressure by mask, passive leg raising, and maximal hand-grip. Ultrasound heart images captured before and during.
Read the detailed description
With focus on atrial wall strain and strain-rate, In healthy volunteer adult subjects, heart ultrasound is recorded during resting, Valsalva manoeuver, Muller manoeuver, passive leg raising, and handgrip. Echocardiographic recordings are made before and during each intervention. Participants are otherwise resting in a reclined position.
- Conditions
- Healthy
- Being tested
- Simple breathing manuevers during brief echocardiographic imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple breathing manuevers during brief echocardiographic imagingOther
Valsalva, Muller, light mask CPAP, leg raising, hand grip.
| Study group | Role | What they receive |
|---|---|---|
| Single arm, breathing manuevers | Experimental | All subjects perform/undergo Valsalva, Muller, CPAP, hand grip, and passive leg raise, with ultrasound examination of heart recorded before and during the manoeuvre. Receives: Other: Simple breathing manuevers during brief echocardiographic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in atrial wall stress during breathing manoeuver, compared to control measurement immediately before the breathing manoeuver
Echocardiographic measure, comparing control measurement to measurement during breathing manoeuver
Measured: 30 seconds, i.e. control measurement and then measurement during breathing manoeuver observed from same breathing/measurement sequence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start18 Nov 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
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 HealthyStudies 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
- Single group
- Model description
- Healthy reclining adult volunteers, with Valsalva manoeuver, Muller manoeuver, light continuous positive airway pressure by mask, passive leg raising, and maximal hand-grip. Ultrasound heart images captured before and during.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Västerbotten
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436030
- Sponsor's protocol ID
- 2017-327-31M
- Status last verified
- Feb 2018
- First submitted
- 15 Dec 2017
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gottfridsson P, A'Roch R, Lindqvist P, Law L, Myrberg T, Hultin M, A'Roch A, Haney M. Left atrial contraction strain and controlled preload alterations, a study in healthy individuals. Cardiovasc Ultrasound. 2022 Mar 30;20(1):8. doi: 10.1186/s12947-022-00278-1.
PubMed 35354482
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atrial and Ventricular Wall Stress, Effects of Breathing and Airway Pressure
- ClinicalTrials.gov ID
- NCT03436030
- Acronym / sponsor ID
- 2017-327-31M
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Västerbotten
- Study start
- 18 Nov 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 19 Feb 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.
Healthy reclining adult volunteers, with Valsalva manoeuver, Muller manoeuver, light continuous positive airway pressure by mask, passive leg raising, and maximal hand-grip. Ultrasound heart images captured before and during.
Detailed description
With focus on atrial wall strain and strain-rate, In healthy volunteer adult subjects, heart ultrasound is recorded during resting, Valsalva manoeuver, Muller manoeuver, passive leg raising, and handgrip. Echocardiographic recordings are made before and during each intervention. Participants are otherwise resting in a reclined position.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Healthy reclining adult volunteers, with Valsalva manoeuver, Muller manoeuver, light continuous positive airway pressure by mask, passive leg raising, and maximal hand-grip. Ultrasound heart images captured before and during.
| Arm | Type | Receives |
|---|---|---|
| Single arm, breathing manuevers | Experimental | Other: Simple breathing manuevers during brief echocardiographic imagingAll subjects perform/undergo Valsalva, Muller, CPAP, hand grip, and passive leg raise, with ultrasound examination of heart recorded before and during the manoeuvre. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy adults
Key exclusion criteria (1 listed)
- known heart or lung disease
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 |
|---|---|---|
| Simple breathing manuevers during brief echocardiographic imagingValsalva, Muller, light mask CPAP, leg raising, hand grip. | Other | Single arm, breathing manuevers |
Primary outcome
Change in atrial wall stress during breathing manoeuver, compared to control measurement immediately before the breathing manoeuver
Time frame: 30 seconds, i.e. control measurement and then measurement during breathing manoeuver observed from same breathing/measurement sequence
Echocardiographic measure, comparing control measurement to measurement during breathing manoeuver
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 22 Apr 2019.
- Derived from this study: PubMed 35354482Gottfridsson P, A'Roch R, Lindqvist P, Law L, Myrberg T, Hultin M, A'Roch A, Haney M. Left atrial contraction strain and controlled preload alterations, a study in healthy individuals. Cardiovasc Ultrasound. 2022 Mar 30;20(1):8. doi: 10.1186/s12947-022-00278-1.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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 Simple breathing manuevers during brief echocardiographic imaging in people with Healthy, run by Umeå University at 1 site in Sweden.
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 22 Apr 2019. 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 Sweden. 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?
Change in atrial wall stress during breathing manoeuver, compared to control measurement immediately before the breathing manoeuver (time frame: 30 seconds, i.e. control measurement and then measurement during breathing manoeuver observed from same breathing/measurement sequence). 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 NCT03436030, 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 22 Apr 2019.