A Novel Device for the Treatment of Postural Hypotension - a Signal of Effectiveness Study.

Launched by ISOTECH LTD · Sep 8, 2023

Keywords

ClinConnect Summary

This clinical trial is testing a new medical device called ISO-101 to help people with a condition known as orthostatic hypotension (OH), which causes a significant drop in blood pressure when standing up. The main goals of the study are to see if the ISO-101 device is effective in improving blood pressure and to ensure it is safe for use in patients with this condition. Participants will take part in the study by using the device in a controlled setting, where their blood pressure and other important health markers will be measured before and after they stand up.

To be eligible for the trial, participants should be adults over 18 years old who have been diagnosed with orthostatic hypotension and experience a noticeable drop in blood pressure when standing. They need to be able to stand up with or without assistance. However, certain individuals, like those who are pregnant, those with severe high blood pressure, or those who cannot follow the study procedures, will not be able to participate. If you join this trial, you can expect to contribute to important research that could lead to better treatments for OH, while also being monitored closely for your safety.

Gender

ALL

Eligibility 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