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

Isotech Ltd

Status: Enrolling

Conditions: Orthostatic Hypotension

Treatments: Device: ISO-101

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06039410

ISO0001

Details and patient eligibility

About

The goal of this clinical trial is to test a novel medical device (ISO-101) in patients diagnosied with orthostatic hypotension. The main question[s] it aims to answer are:

• to determine whether the ISO-101 device demonstrates a signal of efficacy in people with OH and whether it is worthy of further clinical evaluation.
• Assess the safety and performance of the ISO-101 device in patients with orthostatic hypotension.

Participants will use the device under controlled conditions and have the following parameters measured before and after standing up:

• blood pressure
• markers of peripheal vascular resistence
• sympathetic nervous system activity measure before and after standing up

Full description

This is a proof of principle study aimed at evaluating if there is a signal of efficacy from use of the ISO-101 device in people with orthostatic hypotension. The study is a single centre, unblinded, pre-post study. All participants will act as their own control, and all will receive the intervention.The primary objective is to determine whether the ISO-101 device demonstrates a signal of efficacy in people with OH and whether it is worthy of further clinical evaluation.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Treatment

Experimental group

Description:

ISO-101 Device

Treatment:

Device: ISO-101