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Not yet recruitingNCT07850726Updated Sep 30, 2026

Deep Learning-Based Automated Pressure-Strain Loop Analysis

An interventional study of Sustained Isometric Handgrip Exercise and Semi-Supine Bicycle Exercise in Heart Failure, sponsored by Norwegian University of Science and Technology. Not yet recruiting at 1 site in Norway. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Norwegian University of Science and Technology · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Heart Failure

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Keywords

  • Myocardial work
  • Pressure-strain loop
  • Artificial intelligence
  • Deep learning
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Heart failure participants:

  • Unstable disease
  • Contraindication to exercise testing or echocardiography, as judged by an experienced cardiologist

Healthy volunteers:

  • Hypertension
  • Diabetes mellitus
  • Dyslipidemia
  • Current smoking
  • Pregnancy
  • Significant systemic disease
  • Cardioactive medication affecting heart rate, myocardial contractility, or vascular tone
  • Echocardiographic findings suggesting structural heart disease
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (estimated)

Study arms

  • Experimental
    Participants With Heart Failure

    Participants undergo echocardiography at rest, during sustained handgrip, and during semi-supine bicycle exercise.

    Behavioral: Sustained Isometric Handgrip Exercise · Behavioral: Semi-Supine Bicycle Exercise

  • Experimental
    Healthy Volunteers

    Healthy volunteers undergo echocardiography at rest, during sustained handgrip, and during semi-supine bicycle exercise.

    Behavioral: Sustained Isometric Handgrip Exercise · Behavioral: Semi-Supine Bicycle Exercise

Interventions

  • BehavioralSustained Isometric Handgrip Exercise

    Participants perform sustained isometric handgrip at around 30 % of maximal voluntary contraction for 5 minutes during echocardiography.

  • BehavioralSemi-Supine Bicycle Exercise

    Participants perform graded semi-supine bicycle exercise during echocardiography.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Echocardiograms acquired at rest and during handgrip and bicycle exercise at a single study visit.

06

Study locations

1 site
07

References and documents

Individual participant data

Plan to share: No — Individual participant data sharing is not currently planned. Any future sharing would require appropriate ethical, institutional, and data-protection approvals.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07850726
Lead sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
Responsible party
Sponsor
First posted
Sep 30, 2026
Start date
Sep 2026 (estimated)
Primary completion
May 2027 (estimated)
Completion
May 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Håvard Dalen, Professor Havard Dalen, MD, Ph
Contact
havard.dalen@ntnu.no
+4772828027

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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