Non-invasive Pressure-Volume Analysis (NIPVA)

If the heart fails to pump a sufficient amount of blood, it is crucial to know why in order to provide the best treatment. Pressure-volume analysis is the gold standard for evaluating the heart's pumping function. Unfortunately, current techniques are invasive, so most patients will not get this examination. By combining the strengths of echo-Doppler ultrasound, blood pressure monitoring and biomedical computing, the investigators aim to develop a non-invasive method for pressure-volume analysis, extending its applicability to more patients and settings.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust, Hammersmith Hospital

London, W12 0HS, United Kingdom

About this study

Background: Current methods to evaluate left ventricular (LV) function either are invasive, precluding routine use in the majority of patients, or fail to discriminate myocardial, hemodynamic and structural factors, rendering assessment imprecise and incomplete.

Key question: Can we reliably obtain LV functional characteristics by non-invasive means, while being able to differentiate more precisely the factors involved? Proposed research: The study team aims to develop a non-invasive method for pressure-volume analysis (NIPVA) of the LV by combining echo-Doppler, peripheral blood pressure measurements and biomechanical modelling. The validity of this approach will be established by comparison with gold standard invasive measurements of pressure-volume relationships in patients undergoing cardiac catheterization. Test-retest reproducibility will be also assessed. The study team hypothesises that NIPVA will provide reproducible and valid measures of LV function and be more widely applicable.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Individuals, male or female, aged 18-80 years.
30 patients awaiting elective diagnostic coronary angiography will be recruited.
30 patients attending cardiology out-patient clinics will be recruited.

Exclusion criteria

Patients with atrial fibrillation or other dysrhythmias or those unable to fully comply with the protocol will be excluded

Treatment and study plan

Primary outcomes

Reproducibility of non-invasive pressure-volume analysis.

Time frame: Immediate

Reproducibility of test-retest non-invasive pressure-volume analysis
Agreement between invasive and non-invasive pressure-volume analysis

Time frame: Immediate

Agreement between invasive and non-invasive pressure-volume analysis

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Non-invasive Pressure-Volume Analysis (NIPVA): Extending Comprehensive Left Ventricular Pump Function Assessment to More Patients and Settings

Acronym: NIPVA

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Oct 11, 2013
Registry last updated: Apr 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed