A Study of the Prevalence and Causes of Anaemia in Aortic Stenosis
Research type
Research Study
Full title
A Study to Investigate the Prevalence and Causes of Anaemia in Patients with Aortic Stenosis, with Particular Emphasis on the Role of Acquired von Willebrand Factor Deficiency
IRAS ID
167969
Contact name
Ferrah Choudhary
Contact email
Sponsor organisation
Nottingham University Hospitals NHS Trust
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
The study will investigate patients with aortic stenosis (restriction of the aortic valve in the heart) over an eighteen month period. A registry of patients with aortic stenosis will be established and include documentation of haemoglobin levels and the presence and causes of anaemia in a range of patients with aortic stenosis.
In addition, the study aims to evaluate changes in the haemoglobin (blood count) levels of these patients over time.
Appropriate patients will be identified through the institute’s echocardiography department and Valve Register. The patients will be invited to attend an interview, fill in a questionaire and undergo a consultation about their symptoms and other pre-existing medical conditions, including completion of the ISTH bleeding assessment tool.
An ECG (electrical recording of the heart) will be performed. Permission will be requested to extract data from previous echocardiograms (ultrasound scan of the heart). The participants will also have a blood test to measure their blood count, iron levels and kidney function.
A cohort of patients with aortic stenosis will be invited to have coagulation screening and measure levels of von Willebrand factor activity/ platelet function. This will be repeated in these patients at 12 months.
Subject to funding: Patients who undergo treatment of their condition with either surgical aortic valve replacement, balloon valvuloplasty and transcatheter aortic valve replacement, will have post procedure ECG and echocardiograms performed as part of their standard care. In addition, the study proposes a post procedure blood test to check von Willebrand factor activity.
All patients will be followed up at 12 months. At this time, if not already performed, the patients will undergo surveillance ECGs, echocardiography and blood tests (for haemoglobin levels and von Willebrand activity). They will also fill out questionaires about their bleeding history and document any new bleeding events according to the ISTH bleeding assessment tool.
REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
15/EM/0299
Date of REC Opinion
23 Jul 2015
REC opinion
Further Information Favourable Opinion