CONtrol, Fludrocortisone OR Midodrine for the treatment of Orthostatic Hypotension (CONFORM-OH): a randomised controlled trial

ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 13 人开始时间: 2021年7月23日最近更新: 2024年7月22日

适应症

试验速览

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•Current inclusion criteria as of 12/02/2024:
•1. Aged aged 18 years and over
•2. Clinical diagnosis of symptomatic orthostatic hypotension (OH) which is either:
•i.Clinically significant where you would wish to start treatment quickly without a trial of lifestyle modification OR
•ii.Refractory to an adequate period of lifestyle modification (to be judged clinically)
•3. A drop in systolic blood pressure of =20 mmHg and/or a drop in diastolic blood pressure of =10 mmHg, within three minutes of standing upright from a supine position (or on tilt-testing) which has been obtained in the preceding eight weeks
•4. A score of f =2 on the Orthostatic Hypotension Questionnaire (OHQ)
•5. Willing and able to provide informed consent prior to any trial procedures taking place
•Previous inclusion criteria:
•1. Aged =18 years
•2. Clinical diagnosis of symptomatic orthostatic hypotension (OH) refractory to a minimum of 4 weeks of lifestyle modification
•3. Drop in systolic blood pressure of =20 mmHg and/or a drop in diastolic blood pressure of =10 mmHg, within 3 min of standing upright from a supine position which has been obtained in the preceding 8 weeks
•4. Orthostatic Hypotension Questionnaire (OHQ) score of =2
•5. Willing and able to provide informed consent prior to any trial procedures taking place

•1. Orthostatic hypotension (OH) secondary to acute or reversible causes such as haemorrhage or sepsis
•2. Use of fludrocortisone or midodrine within the last six months
•3. Terminal illness or life expectancy <12 months
•4. Unable to stand upright without assistance
•5. Supine hypertension (where the risks of treatment outweigh the benefits) at baseline
•6. Known allergy to study medication
•7. Known contra-indication to fludrocortisone or midodrine which outweighs the potential clinical benefit, for example, if in usual clinical care the clinician and participant feel the risks outweigh the benefits, they would be excluded
•8. Current or planned pregnancy or breast feeding during the trial period. If randomised to either pharmacological arm the participant, if of child-bearing potential, must have a negative urine beta-human chorionic gonadotropin (ß-hCG) pregnancy test and are required to use a highly effective contraceptive method during the trial.
•9. Inability to communicate in English
•10. Inability to comply with the study procedures as specified in the schedule of events
•12. Currently taking part in another clinical trial that would interfere with the outcomes of CONFORM-OH

发起方

ewcastle upon Tyne Hospitals NHS Foundation Trust