NCT01960894

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 11, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

April 11, 2022

Status Verified

January 1, 2020

Enrollment Period

2.3 years

First QC Date

October 9, 2013

Last Update Submit

April 1, 2022

Conditions

Heart Failure

Keywords

Heart Failure

Outcome Measures

Primary Outcomes (2)

  • Reproducibility of non-invasive pressure-volume analysis.

    Reproducibility of test-retest non-invasive pressure-volume analysis

    Immediate

  • Agreement between invasive and non-invasive pressure-volume analysis

    Agreement between invasive and non-invasive pressure-volume analysis

    Immediate

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending cardiology out-patient clinics

You may qualify if:

  • Individuals, male or female, aged 18-80 years.
  • patients awaiting elective diagnostic coronary angiography will be recruited.
  • patients attending cardiology out-patient clinics will be recruited.

You may not qualify if:

  • Patients with atrial fibrillation or other dysrhythmias or those unable to fully comply with the protocol will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College Healthcare NHS Trust, Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

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

    PMID: 31161882RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Alun Hughes

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2013

First Posted

October 11, 2013

Study Start

October 1, 2013

Primary Completion

January 1, 2016

Study Completion

October 1, 2016

Last Updated

April 11, 2022

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)