Clinical trial NCT01960894: Non-invasive Pressure-Volume Analysis (NIPVA)
Official title: Non-invasive Pressure-Volume Analysis (NIPVA): Extending Comprehensive Left Ventricular Pump Function Assessment to More Patients and Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients attending cardiology out-patient clinics

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reproducibility of non-invasive pressure-volume analysis.
timeFrame: Immediate
measure: Agreement between invasive and non-invasive pressure-volume analysis
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust, Hammersmith Hospital
Study officials:
affiliation: Imperial College London
name: Alun Hughes
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.