A Comparison of Advanced Imaging Techniques in Aortic Stenosis

NCT01775215 | Withdrawn

• 1 other identifier: 12/LO/1846
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Need for aortic valve replacement

  1 year

Secondary Outcomes (1)

• Improvement in measured indices post aortic valve replacement

  6 months

Other Outcomes (2)

• The change in rate of measured indices over time

  6 months - 1 year

• The relative change in measured indices between each other over time

  6 months - 1 year

Study Arms (2)

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

Cardiac I123-MIBG Scintigraphy RADIATION

A - Symptomatic severe AS; B - Asymptomatic moderate to severe AS

Cardiac MRI OTHER

A - Symptomatic severe AS; B - Asymptomatic moderate to severe AS

Stress and rest Echocardiogram OTHER

A - Symptomatic severe AS; B - Asymptomatic moderate to severe AS

High Sensitivity Troponin I OTHER

A - Symptomatic severe AS; B - Asymptomatic moderate to severe AS

Brain Natriuretic Peptide OTHER

A - Symptomatic severe AS; B - Asymptomatic moderate to severe AS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead

Study Sites (1)

Harefield Hospital

London, UB9 6JH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum sample.

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Andrew Kelion, MRCP DM

  Royal Brompton and Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 22, 2013
• First Posted: January 24, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2016
• Last Updated: December 2, 2014

Record last verified: 2014-11

Locations

GB (1)