Pilot and feasibility studies · 2025
Control, Fludrocortisone or Midodrine for the treatment of Orthostatic Hypotension (CONFORM-OH): results from an internal pilot randomised controlled trial.
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Mossop Helen, Al-Ashmori Sarah, Sotire Tumi, Clark Emma, Watson Gillian, Witham Miles D, Vale Luke, McGregor Naomi, Phillipson Julia, Wason James M S, Yarnall Alison J, Parry Steve, Hancock Helen, Kenny Rose Anne, Frith James
Аннотация
BACKGROUND: Orthostatic hypotension (OH) is a common debilitating condition characterised by a significant drop in blood pressure (BP) on standing upright. Adults with OH are typically offered non-pharmacologic therapies, either alone or in combination with medication. The two most used agents are fludrocortisone and midodrine. There is a lack of good quality evidence for any of these treatments, all of which are in widespread clinical use. The aim of this internal pilot trial was to evaluate recruitment, attrition, treatment crossover and quality of outcomes.
METHODS: The trial was designed as a pragmatic, open-label, randomised, prospective, multicentre, superior and multi-arm internal pilot. Recruitment was for 10 months, during which we aimed to open 14 sites and recruit a target of 64 adults with OH to evaluate feasibility of recruitment. Attrition, crossover and data collection were also assessed. Participants were randomised to one of three treatments: nondrug therapies (control), fludrocortisone plus nondrug therapies or midodrine plus nondrug therapies. Outcomes measured included symptoms, quality of life, activities of daily living, postural BP, use of health and care services, falls and safety. Participants received treatment and were followed up for 12 months. Pre-planned criteria to progress from internal pilot were defined for recruitment, retention, crossover and outcome completion.
RESULTS: Between the 3rd December 2021 and 31st August 2022, 13 participants were randomised from 4 of 9 recruiting centres. Redeployment of clinical and research staff, due to COVID-19, limited the number of available sites. Participants already receiving fludrocortisone or midodrine accounted for 120 of 233 eligible participants being excluded. Due to the low sample size, the rates of attrition and crossover are of limited value. Apart from the falls diaries, completion rates of the outcome measures were high (> 80%). Due to low recruitment rates, the pilot did not progress to the planned multi-arm multistage trial.
CONCLUSIONS: In its current design, this trial was not feasible. The main barriers to success were participants already receiving treatment and redeployment of clinical and academic staff during and after the COVID-19 pandemic.
TRIAL REGISTRATION: ISRCTN 87213295, 23 July 2021, https://www.isrctn.com/ISRCTN87213295.
METHODS: The trial was designed as a pragmatic, open-label, randomised, prospective, multicentre, superior and multi-arm internal pilot. Recruitment was for 10 months, during which we aimed to open 14 sites and recruit a target of 64 adults with OH to evaluate feasibility of recruitment. Attrition, crossover and data collection were also assessed. Participants were randomised to one of three treatments: nondrug therapies (control), fludrocortisone plus nondrug therapies or midodrine plus nondrug therapies. Outcomes measured included symptoms, quality of life, activities of daily living, postural BP, use of health and care services, falls and safety. Participants received treatment and were followed up for 12 months. Pre-planned criteria to progress from internal pilot were defined for recruitment, retention, crossover and outcome completion.
RESULTS: Between the 3rd December 2021 and 31st August 2022, 13 participants were randomised from 4 of 9 recruiting centres. Redeployment of clinical and research staff, due to COVID-19, limited the number of available sites. Participants already receiving fludrocortisone or midodrine accounted for 120 of 233 eligible participants being excluded. Due to the low sample size, the rates of attrition and crossover are of limited value. Apart from the falls diaries, completion rates of the outcome measures were high (> 80%). Due to low recruitment rates, the pilot did not progress to the planned multi-arm multistage trial.
CONCLUSIONS: In its current design, this trial was not feasible. The main barriers to success were participants already receiving treatment and redeployment of clinical and academic staff during and after the COVID-19 pandemic.
TRIAL REGISTRATION: ISRCTN 87213295, 23 July 2021, https://www.isrctn.com/ISRCTN87213295.