Control, Fludrocortisone or Midodrine for the treatment of Orthostatic Hypotension (CONFORM-OH): results from an internal pilot randomised controlled trial.
Helen Mossop, Sarah Al-Ashmori, Tumi Sotire, Emma Clark, Gillian Watson, Miles D Witham, Luke Vale, Naomi McGregor, Julia Phillipson, James M S Wason, Alison J Yarnall, Steve Parry, Helen Hancock, Rose Anne Kenny, James Frith
{"title":"Control, Fludrocortisone or Midodrine for the treatment of Orthostatic Hypotension (CONFORM-OH): results from an internal pilot randomised controlled trial.","authors":"Helen Mossop, Sarah Al-Ashmori, Tumi Sotire, Emma Clark, Gillian Watson, Miles D Witham, Luke Vale, Naomi McGregor, Julia Phillipson, James M S Wason, Alison J Yarnall, Steve Parry, Helen Hancock, Rose Anne Kenny, James Frith","doi":"10.1186/s40814-025-01704-7","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>ISRCTN 87213295, 23 July 2021, https://www.isrctn.com/ISRCTN87213295.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"118"},"PeriodicalIF":1.6000,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12465824/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Pilot and Feasibility Studies","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s40814-025-01704-7","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0
Abstract
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.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
