HypertensionNCT03089385
Use of a Hypertension Tool to Manage Blood Pressure in Hemodialysis
A study testing Hypertension tool in people with Hypertension, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The objective of this project is to develop, validate, and implement a tool to help manager hypertension in patients on hemodialysis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Hypertension tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- 22 Feb 2016to 9 Apr 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- Receiving in-centre HD for at least 3 months
- Considered hypertensive based on a median intradialytic blood pressure ≥ 140/90 mmgHG
Who cannot join
- Are unable to provide informed consent
- Are deemed medically unstable by the primary physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development, Validation, and Implementation of a Clinical Decision Tool for Blood Pressure Management in Patients on Hemodialysis
The objective of this project is to develop, validate, and implement a tool to help manager hypertension in patients on hemodialysis.
- Conditions
- Hypertension
- Being tested
- Hypertension tool
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertension toolOther
An algorithm developed by staff at UHN to help manage hypertension in hemodialysis patients.
| Study group | Role | What they receive |
|---|---|---|
| Implementation group | Experimental | This group will have the hypertension tool implemented on them. Receives: Other: Hypertension tool |
| Control group | No intervention | This group will not have the tool implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2017
- Study start22 Feb 2016
- Primary completion9 Apr 2021
- Study completion9 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marisa Battistella, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03089385
- Sponsor's protocol ID
- 15-9951
- Status last verified
- Apr 2021
- First submitted
- 20 Mar 2017
- Last updated
- 6 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No