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Contact Information:

Dr Thomas Upton
+44 1173313167
thomas.upton@bristol.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - A pilot study of a new technology for the investigation of high blood pressure in humans

A pilot study of a new technology for the investigation of high blood pressure in humans

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Understanding the relationship between blood pressure and catecholamine rhythms in health and in secretory paraganglioma/phaeochromocytoma


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


The purpose of this research is to generate pilot data to demonstrate how we could use detailed information about rhythms of special group of hormones called catecholamines to tell us more about blood pressure changes in health and disease. High blood pressure (hypertension) is common and often leads to poor health especially if it becomes a long-term condition. Even though it is common, in most people, the cause remains unknown. What we do understand is that, in at least some circumstances, abnormal levels of chemical messengers (hormones) can contribute. We also know that many activities in the body including blood pressure and hormones change across the day, in a rhythmic pattern. However, normally it is very difficult to measure hormone dynamics in detail without a complicated hospital admission. We think that understanding the relationships between rhythms of hormones and blood pressure is important because it will help improve our knowledge of what causes hypertension in the first place.
We will use a novel method called U-RHYTHM microdialysis. This allows us to sample hormones very frequently without taking any blood, and allows the person being sampled to continue normal activities, out of hospital, in a more natural setting. As this is a first-of-its kind investigation, we are testing in a small number of people in anticipation of a future, larger trial. We will test healthy people and compare the results with a group of patients with severe hypertension due to a rare disease called phaeochromocytoma, which results from catecholamine excess. We will also compare the results from the U-RHYTHM method with ‘traditional’ tests like blood samples and blood pressure. We believe that the U-RHYTHM method will provide very important new information that could eventually lead to improvements in the diagnosis and treatment of hypertension.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Nov 2022 01 Jun 2024

1. A baseline observation period of 7 days in which activity and glucose are monitored automatically by wearable devices
2. Wearing our portable U-RHYTHM sampling device for approximately 24 hours, along with an ambulatory blood pressure monitor, heart rate monitor, and continued glucose and activity measurements.
3. Providing 1 blood sample and collecting urine in a bottle over the sample 24 hours
4. For patients, being invited to participate again after surgical treatment for their condition


Healthy males and females aged over 16, and patients with a diagnosis of secretory phaeochromocytoma or paraganglioma

You can take part if:



You may not be able to take part if:


1. Inability to attend study visits due to location2. Positive urine drug screen (drugs of abuse – cocaine, methamphetamines etc) as these will alter catecholamine measurements3. History of intravenous drug use - any4. Current pregnancy, breast feeding

Patients:5. Use of medication known to significantly interfere with measurement of metanephrines within 48 hours of or during the microdialysis sampling period

Healthy volunteers:6. Any active medical condition7. Any regular prescribed medication8. Use of any prescribed, over-the-counter, herbal or other medication within or during the 48 hours of microdialysis sampling period, or, at the investigator’s discretion, 9. Significant hypertension at screening (SBP >160/DBP >100)10. Night shift work or international travel (more than 2 time zones) within the previous 60 days 11. Regular intake of alcohol well in excess of recommended weekly consumption


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Southmead Hospital
    Southmead Road Westbury-on-trym
    Bristol
    BS10 5NB
  • University of Bristol
    Senate House Tyndall Avenue
    Bristol
    BS8 1TH
  • Evangelismos Hospital
    Endocrinology Department AHEPA Building 45-47 Ipsilantou Str
    Athens
    10676

There are no direct benefits but the data will contribute to new knowledge in the field, and results from the study will be shared with the participants if they wish. Risk is very minimal as previous trials have shown U-RHYTHM sampling to be very safe. There is a small risk that a previously undiagnosed medical condition may be revealed as part of the investigation in which case this will be discussed and referred for further assessment as appropriate.

Dr Thomas Upton
+44 1173313167
thomas.upton@bristol.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Bristol and funded by Wellcome Trust.




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Read full details for Trial ID: ISRCTN64279315

Or CPMS 53468

Last updated 04 December 2023

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