SEE-HF Study
Research type
Research Study
Full title
Screening For Advanced Heart Failure Treatment
IRAS ID
131678
Contact name
Steven Shaw
Contact email
Sponsor organisation
Thoratec Europe Limited
Research summary
Heart Failure (HF) affects approximately 1 million people in the UK and may carry a poor prognosis. Cardiologists and HF specialist teams are accustomed with conventional treatments including medication and pacemaker therapies. However, it is expected that a significant number of patients are not referred at an appropriate time for advanced therapies such as heart transplantation or left ventricular assist devices (LVAD), who might otherwise benefit from these.
This is a multi centre, international observatory study that is already underway at several European centres. The aim is to determine what proportion of heart failure patients in a pacemaker device clinic have evidence of poor prognosis yet have not been assessed for their suitability for transplantation or LVAD.
Hospital notes will be screened to see if poor heart function is present (LVEF <40%)and significant symptoms have been reported (NYHA III/IV) despite appropriate device and medical therapy. If they meet this criteria, they will be approached for recruitment which involves a full assessment by an advanced heart failure team. This includes exercise tests, updated hearts scans, quality of life questionnaires etc. All tests and consultations performed are not considered a deviation from standard practice as patients fulfilling the entry criteria should have an assessment by an advanced heart failure cardiologist (as endorsed by UK and international guidelines).
After consultation, it will be determined whether the patient is a potential transplant or LVAD candidate. A full discussion with the patient will occur irrespective of the outcome, advising them of their options and if appropriate - ongoing management. Patients will be followed up for a period of 12 months to track their outcomes, whether they undergo advanced therapy or not. This will provide additional information about the accuracy of exercise tests and prognostic scores.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
13/SC/0312
Date of REC Opinion
24 May 2013
REC opinion
Favourable Opinion