CONFORM-OH
Research type
Research Study
Full title
Control, Fludrocortisone or Midodrine for the treatment of Orthostatic Hypotension: A Randomised Controlled Trial
IRAS ID
277408
Contact name
James Frith
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Eudract number
2020-000794-25
ISRCTN Number
ISRCTN87213295
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
Orthostatic hypotension (OH) is a drop in blood pressure (BP) on standing up from a sitting or lying position. The drop in BP can lead to unpleasant symptoms such as dizziness, fainting and falls. It is a common problem, affecting one in five older people and one in three people with Parkinson’s disease.
Doctors usually treat OH without tablets and medicines, instead giving patients advice on drinking more water, wearing compression stockings and performing muscle tensing exercises (known as non-drug therapies). When these non-drug therapies don’t help, patients are offered medication. The two most commonly used drugs for OH are fludrocortisone and midodrine. However, there has been very little research on whether these treatments work. So nobody really knows what the ideal treatment is for OH.
Because these treatments are widely used in the NHS, but we do not really know if they work or not, the NIHR has commissioned this piece of research. To find out what the best treatment is, this study will compare fludrocortisone and midodrine to non-drug therapies (known as usual care). We will recruit 366 participants, aged 18 years and over with OH from up to 20 UK NHS hospital sites. Participants will be randomly allocated one of three treatment groups – usual care, fludrocortisone or midodrine. People with OH have told us that symptoms are the most important outcome to them, so we will measure any change in symptoms in all three groups. After participants have been randomised they will receive this intervention for 12 months and will be followed up at 3, 6 and 12 months where they will be given a falls diary to complete, and complete study questionnaires in addition to their routine care. Study visits will be completed as much as possible within the usual routine clinic visits for ease for the participants.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
21/NE/0083
Date of REC Opinion
15 Jun 2021
REC opinion
Further Information Favourable Opinion