Non-invasive Pressure-Volume Analysis (NIPVA)

Heart Failure Clinical Trial

— NIPVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01960894
• Other study ID #: Protocol_NIPVA Study_v1_050613
• Status: Completed
• Start date: October 2013
• Est. completion date: October 2016

Study information

• Verified date: January 2020
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: October 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust, Hammersmith Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Heusinkveld MHG, Delhaas T, Lumens J, Huberts W, Spronck B, Hughes AD, Reesink KD. Augmentation index is not a proxy for wave reflection magnitude: mechanistic analysis using a computational model. J Appl Physiol (1985). 2019 Aug 1;127(2):491-500. doi: 10 — View Citation

Outcome

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