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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01775215
Other study ID # 12/LO/1846
Secondary ID
Status Withdrawn
Phase N/A
First received January 22, 2013
Last updated November 27, 2014
Start date January 2013
Est. completion date January 2016

Study information

Verified date November 2014
Source Royal Brompton & Harefield NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: National Health ServiceUnited Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 2016
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Radiation:
Cardiac I123-MIBG Scintigraphy

Other:
Cardiac MRI

Stress and rest Echocardiogram

High Sensitivity Troponin I

Brain Natriuretic Peptide


Locations

Country Name City State
United Kingdom Harefield Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Other The change in rate of measured indices over time 6 months - 1 year No
Other The relative change in measured indices between each other over time 6 months - 1 year No
Primary Need for aortic valve replacement 1 year No
Secondary Improvement in measured indices post aortic valve replacement 6 months No
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