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

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ClinicalTrials.gov Identifier: NCT01960894
Recruitment Status : Unknown
Verified September 2013 by Imperial College London.
Recruitment status was:  Recruiting
First Posted : October 11, 2013
Last Update Posted : October 11, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Heart Failure

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-invasive Pressure-Volume Analysis (NIPVA): Extending Comprehensive Left Ventricular Pump Function Assessment to More Patients and Settings
Study Start Date : September 2013
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Reproducibility between non-invasive pressure-volume analysis and how comparable with invasive pressure-volume analysis. [ Time Frame: Immediate ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients attending cardiology out-patient clinics
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01960894


Locations
United Kingdom
Imperial College Healthcare NHS Trust, Hammersmith Hospital Recruiting
London, United Kingdom, W12 0HS
Contact: Katherine March, BSc    +44 207    k.march@imperial.ac.uk   
Principal Investigator: Alun D Hughes, PhD         
Sponsors and Collaborators
Imperial College London
More Information

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01960894     History of Changes
Other Study ID Numbers: Protocol_NIPVA Study_v1_050613
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: October 11, 2013
Last Verified: September 2013

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases