Overview

This trial is active, not recruiting.

Condition aortic stenosis
Treatments cardiac i123-mibg scintigraphy, cardiac mri, stress and rest echocardiogram, high sensitivity troponin i, brain natriuretic peptide
Sponsor Royal Brompton & Harefield NHS Foundation Trust
Start date January 2013
End date January 2015
Trial size 105 participants
Trial identifier NCT01775215, 12/LO/1846

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with symptomatic severe aortic stenosis (AS) as per ESC guidelines, requiring aortic valve replacement.
cardiac i123-mibg scintigraphy
cardiac mri
stress and rest echocardiogram
high sensitivity troponin i
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.
cardiac i123-mibg scintigraphy
cardiac mri
stress and rest echocardiogram
high sensitivity troponin i
brain natriuretic peptide

Primary Outcomes

Measure
Need for aortic valve replacement
time frame: 1 year

Secondary Outcomes

Measure
Improvement in measured indices post aortic valve replacement
time frame: 6 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Comparative Study of Advanced Imaging Techniques in Predicting the Clinical Outcome in Aortic Stenosis
Principal investigator Andrew Kelion, MRCP DM
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Royal Brompton & Harefield NHS Foundation Trust.