Clinical trial NCT01775215: A Comparison of Advanced Imaging Techniques in Aortic Stenosis
Official title: A Comparative Study of Advanced Imaging Techniques in Predicting the Clinical Outcome in Aortic Stenosis
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Aortic Stenosis
Keywords: Left Ventricular Function
Aortic Valve Replacement
Late Gadolinium Enhancement
Cardiac I123 MIBG
Longitudinal Strain
Brain Natriuretic Peptide
High Sensitivity Troponin I
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Tertiary care Outpatient population under regular follow by either cardiology or cardio thoracic team.

Brief 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.


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

Primary outcomes:
measure: Need for aortic valve replacement
timeFrame: 1 year
Secondary outcomes:
measure: Improvement in measured indices post aortic valve replacement
timeFrame: 6 months
Other outcomes:
measure: The change in rate of measured indices over time
timeFrame: 6 months - 1 year
measure: The relative change in measured indices between each other over time
timeFrame: 6 months - 1 year
Locations:
city: London
country: United Kingdom
facility: Harefield Hospital
Study officials:
affiliation: Royal Brompton and Harefield NHS Foundation Trust
name: Andrew Kelion, MRCP DM
role: PRINCIPAL_INVESTIGATOR
References: