Testing a new device for treating low blood pressure upon standing
ISO-101 a Novel Device for the Treatment of Orthostatic Hypotension - a Signal of Efficacy Study
This study is testing a new device to see if it can help people with low blood pressure when they stand up feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Isotech Ltd Industry-sponsored |
| Locations | 1 site (Newcastle Upon Tyne) |
| Trial ID | NCT06039410 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of a novel medical device, ISO-101, in patients diagnosed with orthostatic hypotension. Participants will use the device under controlled conditions, with measurements taken before and after standing to assess blood pressure, peripheral vascular resistance, and sympathetic nervous system activity. The study is designed as a single-center, unblinded, pre-post study where each participant serves as their own control. The primary goal is to determine if the ISO-101 device shows a signal of efficacy that warrants further clinical evaluation.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a clinical diagnosis of orthostatic hypotension who experience significant drops in blood pressure upon standing.
Not a fit: Patients with acute or reversible causes of orthostatic hypotension or those unable to use the device due to physical limitations may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a new treatment option for patients suffering from orthostatic hypotension.
How similar studies have performed: While this approach is novel, similar studies evaluating devices for orthostatic hypotension have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willing and able to give informed consent for participation in the study * Adults aged over 18 years with a clinical diagnosis of orthostatic hypotension * A drop in systolic BP of ≥20 mmHg (with or without a drop in diastolic BP ≥10 mmHg) within 3 minutes of standing up from a supine position * Able to stand up from a supine position (with assistance if required) Exclusion Criteria: * Cognitively unable to follow research procedures * Physically unable to use the ISO-101 device (e.g., unilateral arm weakness due to stroke) * Acute or reversible cause of OH (e.g., haemorrhage or sepsis) * Current pregnancy * Participants on insulin (participants will be asked to refrain from breakfast on the morning of their assessment) * Resting supine systolic BP ≥180 or diastolic ≥110 mmHg
Where this trial is running
Newcastle Upon Tyne
- Falls and Syncope Service, Older People's Medicine, The Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle Upon Tyne, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Neil Fawkes, MBChB DPM FFPM
- Email: neil@isotechltd.co.uk
- Phone: +44 (0) 2830 835 500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.