A Comparison of Advanced Imaging Techniques in Aortic Stenosis

Withdrawn

• Conditions: Aortic Stenosis
• Interventions: Radiation: Cardiac I123-MIBG Scintigraphy; Other: Cardiac MRI; Other: Stress and rest Echocardiogram; Other: High Sensitivity Troponin I; Other: Brain Natriuretic Peptide

• Registration Number: NCT01775215
• Lead Sponsor: Royal Brompton & Harefield NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-24
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-27
• Last Update Posted: 2014-12-02
• Primary Completion: 2015-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A - Symptomatic severe AS	Cardiac I123-MIBG Scintigraphy	Patients with symptomatic severe aortic stenosis (AS) as per ESC guidelines, requiring aortic valve replacement.
A - Symptomatic severe AS	Stress and rest Echocardiogram	Patients with symptomatic severe aortic stenosis (AS) as per ESC guidelines, requiring aortic valve replacement.
B - Asymptomatic moderate to severe AS	Cardiac I123-MIBG Scintigraphy	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.
B - Asymptomatic moderate to severe AS	High Sensitivity Troponin I	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.
B - Asymptomatic moderate to severe AS	Cardiac MRI	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.
B - Asymptomatic moderate to severe AS	Brain Natriuretic Peptide	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.
A - Symptomatic severe AS	Cardiac MRI	Patients with symptomatic severe aortic stenosis (AS) as per ESC guidelines, requiring aortic valve replacement.
A - Symptomatic severe AS	High Sensitivity Troponin I	Patients with symptomatic severe aortic stenosis (AS) as per ESC guidelines, requiring aortic valve replacement.
A - Symptomatic severe AS	Brain Natriuretic Peptide	Patients with symptomatic severe aortic stenosis (AS) as per ESC guidelines, requiring aortic valve replacement.
B - Asymptomatic moderate to severe AS	Stress and rest Echocardiogram	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.

Primary Outcome Measures

Name	Time	Method
Need for aortic valve replacement	1 year

Secondary Outcome Measures

Name	Time	Method
Improvement in measured indices post aortic valve replacement	6 months

Trial Locations

Locations (1)

Harefield Hospital; 🇬🇧 London, United Kingdom