Non-invasive Pressure-Volume Analysis (NIPVA)

NCT ID: NCT01960894

Last Updated: 2022-04-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alun Hughes

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Imperial College Healthcare NHS Trust, Hammersmith Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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: 10.1152/japplphysiol.00769.2018. Epub 2019 May 30.

Reference Type RESULT
PMID: 31161882 (View on PubMed)

Other Identifiers

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Protocol_NIPVA Study_v1_050613

Identifier Type: -

Identifier Source: org_study_id

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