Orthostatic hypotension Circulatory System Orthostatic hypotension
Conditions
Interventions
The study will compare conservative management, conservative management plus fludrocortisone, and conservative management plus midodrine in a randomised parallel trial, with a 10-month internal pilot.
conservative management only (non-pharmacologic treatments), conservative management plus fludrocortisone, or conservative management plus midodrine. Randomisations will be carried out by a delegated
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptoms of orthostatic hypotension measured using change in the Orthostatic Hypotension Questionnaire (OHQ) score at baseline and 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life measured using the EuroQol 5-dimension 5-level (EQ-5D-5L) questionnaire at baseline, 3, 6, and 12 months 2. Activities of daily living (ADLs) measured using the Nottingham Extended ADL scale at baseline, 3, 6, and 12 months 3. Falls (number of falls, number of fallers/non-fallers, fall rate per person-year, time to first fall, fall-related injuries, and number of syncopal events) measured using participant diary at baseline, 3, 6, and 12 months 4. Standing blood pressure and postural blood pressure drop measured using sphygmomanometer at baseline, 3, 6, and 12 months 5. Quality-adjusted life years (QALYs) estimated from responses to the EQ-5D-5L questionnaire at baseline, 3, 6, and 12 months 6. Costs to the NHS, personal social services, and patients measured using ... at 12 months 7. Cost-effectiveness of each treatment strategy modelled from a patient and NHS and personal social services perspective measured in terms of the incremental costs per QALY gained at 12 months 8. Side effects and the safety data associated with each treatment strategy measured using participant records at baseline, 3, 6, and 12 months | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactEmma Clark
Outcome results
None listed