Non-invasive Pressure-Volume Analysis (NIPVA)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01960894

Acronym

NIPVA

Enrollment

Registered

2013-10-11

Start date

2013-10-31

Completion date

2016-10-31

Last updated

2022-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

Heart Failure

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Reproducibility of non-invasive pressure-volume analysis.	Immediate	Reproducibility of test-retest non-invasive pressure-volume analysis
Agreement between invasive and non-invasive pressure-volume analysis	Immediate	Agreement between invasive and non-invasive pressure-volume analysis

Countries

United Kingdom

Outcome results