Fludrocortisone and midodrine for the treatment of orthostatic hypotensio
- Conditions
- Orthostatic hypotensionCirculatory System
- Registration Number
- ISRCTN87213295
- Lead Sponsor
- ewcastle upon Tyne Hospitals NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 13
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Symptoms of orthostatic hypotension measured using change in the Orthostatic Hypotension Questionnaire (OHQ) score at baseline and 6 months.
- Secondary Outcome Measures
Name Time Method