Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Imperial College London
Information provided by (Responsible Party):
Imperial College London Identifier:
First received: October 9, 2013
Last updated: October 10, 2013
Last verified: September 2013

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.

Heart Failure

Study Type: Observational
Study Design: 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

Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Reproducibility between non-invasive pressure-volume analysis and how comparable with invasive pressure-volume analysis. [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients attending cardiology out-patient clinics


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01960894

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

No publications provided

Responsible Party: Imperial College London Identifier: NCT01960894     History of Changes
Other Study ID Numbers: Protocol_NIPVA Study_v1_050613
Study First Received: October 9, 2013
Last Updated: October 10, 2013
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases processed this record on February 26, 2015