Heart FailureNCT07850726
Deep Learning-Based Automated Pressure-Strain Loop Analysis
A study testing Sustained Isometric Handgrip Exercise and Semi-Supine Bicycle Exercise in people with Heart Failure, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
Noninvasive left ventricular pressure-strain loop analysis estimates myocardial work from longitudinal strain, brachial systolic blood pressure, and cardiac valve-event timing. It provides global work index, constructive work, wasted work, and work efficiency. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sustained Isometric Handgrip Exercise and Semi-Supine Bicycle Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Heart failure participants:
- Age ≥18 years
- Able to provide informed consent
- Previous myocardial infarction
- Left ventricular ejection fraction ≤40% after myocardial infarction
- Healthy volunteers:
- Age ≥18 years
- Able to provide informed consent
Who cannot join
- Heart failure participants:
- Unstable disease
- Contraindication to exercise testing or echocardiography, as judged by an experienced cardiologist
- Healthy volunteers:
- Hypertension
- Diabetes mellitus
Show all 12Show fewer
- Dyslipidemia
- Current smoking
- Pregnancy
- Significant systemic disease
- Cardioactive medication affecting heart rate, myocardial contractility, or vascular tone
- Echocardiographic findings suggesting structural heart disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Norway1 site
St. Olavs hospital
Trondheim, 7006
Ingrid Yttervoll, MD, 90741665, ingrid.yttervoll@ntnu.no
About this study
Noninvasive left ventricular pressure-strain loop analysis estimates myocardial work from longitudinal strain, brachial systolic blood pressure, and cardiac valve-event timing. It provides global work index, constructive work, wasted work, and work efficiency.
This study evaluates a deep-learning method that automates myocardial work and loop-shape analysis. The method may reduce analysis time, improve reproducibility, and identify patterns associated with heart failure.
- Conditions
- Heart Failure
- Being tested
- Sustained Isometric Handgrip Exercise, Semi-Supine Bicycle Exercise
- Keywords
- Myocardial work, Pressure-strain loop, Artificial intelligence, Deep learning
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sustained Isometric Handgrip ExerciseBehavioural
Participants perform sustained isometric handgrip at around 30 % of maximal voluntary contraction for 5 minutes during echocardiography.
Semi-Supine Bicycle ExerciseBehavioural
Participants perform graded semi-supine bicycle exercise during echocardiography.
| Study group | Role | What they receive |
|---|---|---|
| Participants With Heart Failure | Experimental | Participants undergo echocardiography at rest, during sustained handgrip, and during semi-supine bicycle exercise. Receives: Behavioral: Sustained Isometric Handgrip Exercise; Behavioral: Semi-Supine Bicycle Exercise |
| Healthy Volunteers | Experimental | Healthy volunteers undergo echocardiography at rest, during sustained handgrip, and during semi-supine bicycle exercise. Receives: Behavioral: Sustained Isometric Handgrip Exercise; Behavioral: Semi-Supine Bicycle Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic Acquisition Success
Percentage of acquired examinations successfully processed by the deep-learning pipeline to generate myocardial work indices, assessed separately at rest, during handgrip, and during bicycle exercise.
Measured: During one study visit: at rest, during the handgrip and bicycle test.
Secondary outcomes (1)
Agreement Between Deep Learning- and Expert-Derived Myocardial Work Indices
Agreement for myocardial work indices will be assessed using mean bias with 95% limits of agreement, and mean absolute error.
Measured: Echocardiograms acquired at rest and during handgrip and bicycle exercise at a single study visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants with heart failure and healthy controls undergo echocardiography at rest, during sustained handgrip, and during semi-supine bicycle exercise. Within-participant changes and responses between groups are compared.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850726
- Sponsor's protocol ID
- 2019/1059_1
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data sharing is not currently planned. Any future sharing would require appropriate ethical, institutional, and data-protection approvals.
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Learning-Based Automated Pressure-Strain Loop Analysis
- ClinicalTrials.gov ID
- NCT07850726
- Acronym / sponsor ID
- 2019/1059_1
- Conditions
- Heart Failure
- Keywords
- Myocardial work, Pressure-strain loop, Artificial intelligence, Deep learning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 30 Sep 2026 (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.
Noninvasive left ventricular pressure-strain loop analysis estimates myocardial work from longitudinal strain, brachial systolic blood pressure, and cardiac valve-event timing. It provides global work index, constructive work, wasted work, and work efficiency.
This study evaluates a deep-learning method that automates myocardial work and loop-shape analysis. The method may reduce analysis time, improve reproducibility, and identify patterns associated with heart failure.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants with heart failure and healthy controls undergo echocardiography at rest, during sustained handgrip, and during semi-supine bicycle exercise. Within-participant changes and responses between groups are compared.
| Arm | Type | Receives |
|---|---|---|
| Participants With Heart Failure | Experimental | Behavioral: Sustained Isometric Handgrip Exercise, Behavioral: Semi-Supine Bicycle ExerciseParticipants undergo echocardiography at rest, during sustained handgrip, and during semi-supine bicycle exercise. |
| Healthy Volunteers | Experimental | Behavioral: Sustained Isometric Handgrip Exercise, Behavioral: Semi-Supine Bicycle ExerciseHealthy volunteers undergo echocardiography at rest, during sustained handgrip, and during semi-supine bicycle exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥18 years
- Able to provide informed consent
- Previous myocardial infarction
- Left ventricular ejection fraction ≤40% after myocardial infarction
- Age ≥18 years
Key exclusion criteria (12 listed)
- Unstable disease
- Contraindication to exercise testing or echocardiography, as judged by an experienced cardiologist
- Hypertension
- Diabetes mellitus
- Dyslipidemia
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 |
|---|---|---|
| Sustained Isometric Handgrip ExerciseParticipants perform sustained isometric handgrip at around 30 % of maximal voluntary contraction for 5 minutes during echocardiography. | Behavioural | Healthy Volunteers, Participants With Heart Failure |
| Semi-Supine Bicycle ExerciseParticipants perform graded semi-supine bicycle exercise during echocardiography. | Behavioural | Healthy Volunteers, Participants With Heart Failure |
Primary outcome
Echocardiographic Acquisition Success
Time frame: During one study visit: at rest, during the handgrip and bicycle test.
Percentage of acquired examinations successfully processed by the deep-learning pipeline to generate myocardial work indices, assessed separately at rest, during handgrip, and during bicycle exercise.
1 secondary outcome
Agreement Between Deep Learning- and Expert-Derived Myocardial Work Indices
Time frame: Echocardiograms acquired at rest and during handgrip and bicycle exercise at a single study visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data sharing is not currently planned. Any future sharing would require appropriate ethical, institutional, and data-protection approvals.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sustained Isometric Handgrip Exercise and Semi-Supine Bicycle Exercise in people with Heart Failure, run by Norwegian University of Science and Technology 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 8 inclusion and 12 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: opening soon, as of the sponsor's last update on 30 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Håvard Dalen, Professor Havard Dalen, MD, Ph (+4772828027, havard.dalen@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiographic Acquisition Success (time frame: During one study visit: at rest, during the handgrip and bicycle test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2026.