CClinicalTrials.gg
WithdrawnNCT01775215AIm-ASUpdated Dec 2, 2014

A Comparison of Advanced Imaging Techniques in Aortic Stenosis

An observational study in Aortic Stenosis, sponsored by Royal Brompton & Harefield NHS Foundation Trust. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-02.

Sponsored by Royal Brompton & Harefield NHS Foundation Trust · Observational

Why this study was withdrawn
Abandoned
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study summary

In patients with aortic stenosis the valve through which blood is pumped out of the main heart chamber is narrowed. This results in heart muscle working harder to open the valve so blood can circulate around the body. The muscle adapts to the increased pressure load to maintain efficiency. This can cause long-term muscle damage. To predict when this deterioration will require a valve replacement is difficult and untimely operation exposes patients to unnecessary risk.

We aim to compare all validated techniques looking at different aspects of heart muscle strain in these patients. These will be a blood sample measuring a specific hormone (BNP) and enzyme (Troponin), a nuclear scan to assess nerve activation, an MRI identifying scarring and an exercise echocardiogram that measures heart muscle response and pressure changes across the valve. Tests will be performed at recruitment and either after one year or after valve replacement, which ever comes first.

In comparing these different imaging techniques we aim to identify patients who will benefit from an early operation, those whose muscle is likely to recover back to normal and which patients it is safe to wait longer for the surgery, avoiding unnecessary risk.

The results of the study will benefit patients as it will help doctors more accurately assess the timing of valve surgery and improve their prediction of long term heart muscle recovery. It may also increase convenience in clinical management by reducing unnecessary tests and hospital trips. This would translate into cost savings for the NHS.

02

Conditions studied

  • Aortic Stenosis

Keywords

  • Left Ventricular Function
  • Aortic Valve Replacement
  • Late Gadolinium Enhancement
  • Cardiac I123 MIBG
  • Longitudinal Strain
  • Brain Natriuretic Peptide
  • High Sensitivity Troponin I
03

In context

Aortic Valve Stenosis

985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.

Browse Aortic Valve Stenosis studies →

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust is the lead sponsor of 137 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Tertiary care Outpatient population under regular follow by either cardiology or cardio thoracic team.

Eligibility criteria

Inclusion Criteria:

(Group A)

  • Asymptomatic patients with moderate to severe Aortic Stenosis
  • Ejection fraction greater than 50%
  • Not yet being considered for valve surgery

(Group B)

  • Severe Aortic Stenosis (as per ESC guidelines)
  • Listed for immediate aortic valve replacement

Exclusion Criteria: (Group A and B)

  • Inability to provide informed consent
  • Concurrent primary valve lesions greater than mild (as defined by ESC criteria)
  • Previous myocardial infarction (regional wall motion abnormality on resting echo)
  • Cardiomyopathy
  • Congenital heart disease
  • Previous cardiac surgery
  • Renal failure (CKD stage 3, eGFR >30ml/min/1.73m2)
  • Pregnancy, risk of pregnancy, breast feeding
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • A - Symptomatic severe AS

    Patients with symptomatic severe aortic stenosis (AS) as per ESC guidelines, requiring aortic valve replacement.

    Radiation: Cardiac I123-MIBG Scintigraphy · Other: Cardiac MRI · Other: Stress and rest Echocardiogram · Other: High Sensitivity Troponin I · Other: Brain Natriuretic Peptide

  • B - Asymptomatic moderate to severe AS

    Asymptomatic patients with moderate to severe aortic stenosis (AS) as per ESC guidelines ,with Left Ventricular ejection fraction \>50%, not yet requiring aortic valve replacement.

    Radiation: Cardiac I123-MIBG Scintigraphy · Other: Cardiac MRI · Other: Stress and rest Echocardiogram · Other: High Sensitivity Troponin I · Other: Brain Natriuretic Peptide

Interventions

  • RadiationCardiac I123-MIBG Scintigraphy
  • OtherCardiac MRI
  • OtherStress and rest Echocardiogram
  • OtherHigh Sensitivity Troponin I
  • OtherBrain Natriuretic Peptide
06

What researchers measure

Primary outcomes

  1. Need for aortic valve replacement

    Time frame: 1 year

Secondary outcomes

  1. Improvement in measured indices post aortic valve replacement

    Time frame: 6 months

Other outcomes

  1. The change in rate of measured indices over time

    Time frame: 6 months - 1 year

  2. The relative change in measured indices between each other over time

    Time frame: 6 months - 1 year

07

Study locations

1 site
  • Harefield Hospital
    London, UB9 6JH, United Kingdom
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01775215
Lead sponsor
Royal Brompton & Harefield NHS Foundation Trust
Responsible party
Sponsor
First posted
Jan 24, 2013
Start date
Jan 2013
Primary completion
Jan 2015 (estimated)
Completion
Jan 2016 (estimated)
Last update
Dec 2, 2014

Study contacts

Andrew Kelion, MRCP DM
principal investigator · Royal Brompton and Harefield NHS Foundation Trust

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.

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