CONFORM-OH: a new trial for patients with orthostatic hypotension
Dr James Frith is a clinical senior lecturer, working in the Institute for Ageing and Institute of Cellular Medicine at the Newcastle University. He is also a practising clinician, working as a consultant geriatrician in the Newcastle Hospitals NHS Foundation Trust. He tweets @jamesfrith1981
Orthostatic hypotension (OH) is a frequent finding in many of our older patients. It often causes dizziness, unsteadiness and contributes to falls. For some patients, lifestyle advice can be effective, as can stopping medications that contribute to OH. However, there remains a significant number of patients who experience disabling symptoms despite such advice. What should we do to help this group of patients?
There are several drug treatments that can potentially be used, the commonest of which are fludrocortisone and midodrine. However, existing evidence on the effectiveness of these treatments is lacking. Very few trials have included older people with multimorbidity, and most trials to date have focused on changes in blood pressure over a few hours or days, rather than on symptoms and quality of life. So we do not know at the moment whether our patients really benefit from these treatments in terms of their symptoms and overall wellbeing.
The National Institute for Health Research (NIHR) have recognised the need for better evidence in this area. As a result of a recent commissioning call, they have now funded the CONtrol, Fludrocortisone OR Midodrine (CONFORM-OH) trial led by Dr James Frith and colleagues in Newcastle. CONFORM-OH is a multi-centre randomised controlled trial that will recruit from at least 20 centres across the UK. The trial will compare usual care with a strategy of either prescribing fludrocortisone or midodrine.
The trial will be open-label with clinicians using fludrocortisone or midodrine in the same way that they would in their usual practice, titrating the dose up and down as guided by patient symptoms and side effects. The main outcome from the trial will be the Orthostatic Hypotension Questionnaire Symptom Score, which is highly relevant to patient well-being; we will also be measuring quality of life, health economic benefits, falls and side effects. We are aiming to recruit between 350 and 400 older people from across the UK; the trial will recruit people with Parkinsonian syndromes as well as people without Parkinson's disease.
So come and join us! If you are interested in being a recruiting centre for the trial, please contact us and we can share further details with you. We hope that you will randomise your patients into this important trial; we have all bemoaned the lack of evidence in this area for many years and we now have a fantastic opportunity to find out what treatments really work for our patients with OH.
James Frith and Miles Witham
Contact Dr James Frith via james [dot] frith [at] newcastle [dot] ac [dot] uk