Deep Learning-Based Automated Pressure-Strain Loop Analysis

NCT07850726 | Not Yet Recruiting

• 1 other identifier: 2019/1059_1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Heart Failure

Keywords

Myocardial work; Pressure-strain loop; Artificial intelligence; Deep learning

Outcome Measures

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.

  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

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

Study Arms (2)

Participants With Heart Failure

EXPERIMENTAL

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

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.

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

Interventions

Sustained Isometric Handgrip Exercise BEHAVIORAL

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

Healthy Volunteers; Participants With Heart Failure

Semi-Supine Bicycle Exercise BEHAVIORAL

Participants perform graded semi-supine bicycle exercise during echocardiography.

Healthy Volunteers; Participants With Heart Failure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• St. Olavs Hospital: collaborator

Study Sites (1)

St. Olavs hospital

Trondheim, 7006, Norway

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Håvard Dalen, Professor Havard Dalen, MD, Ph

CONTACT

+4772828027; havard.dalen@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 24, 2026
• First Posted: September 30, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)