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HypertensionNCT05378750

Fluid Overload Management and Vascular Stiffness in Chronic Kidney Disease Patients With Hypertension

A study testing Diuretic algorithm in people with Hypertension, run by University of Alberta at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study aims to reduce fluid overload in order to control blood pressure of hypertensive CKD patients using bio-impedance assessment of fluid status and using a diuretic therapy algorithm. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Diuretic algorithm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteCanada
Study dates
1 Nov 2022to 1 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (>18 years old) outpatient with uncontrolled hypertension; defined as, AMBP ≥ 130/80 mmHg despite treatment
  • With an estimated glomerular filtration rate (eGFR) of 15-45 ml/min/1.73 m2.
  • Fluid overload of more than 5% of estimated normal ECFV, as assessed by Bio-impedance spectroscopy (we are using the Body Composition Monitor, a validated device marketed by Fresenius, Canada).

Who cannot join

  • Pregnancy or lactation
  • Declined informed consent
  • Patients with cognitive dysfunction
  • Surgery within six weeks of the study
  • Patients with heart failure, atrial fibrillation, stroke, nephrotic syndrome and active auto-immune disease
  • Patients with severe life-limiting comorbidities like cancer
  • Patients with amputated limbs (despite the fact that the BCM device can be used if people have a unilateral amputation, the home devices measure via 2 legs).

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • University of Alberta

    Edmonton, Alberta, T6G 2P4

Other trials in Canada

About this study

This study aims to reduce fluid overload in order to control blood pressure of hypertensive CKD patients using bio-impedance assessment of fluid status and using a diuretic therapy algorithm.

Read the detailed description

Hypertension is highly prevalent in individuals with chronic kidney disease (CKD). Gradual loss of kidney function is associated with sodium retention. This ultimately leads to fluid overload which has been associated with high blood pressure and heart failure in patients with CKD. In such cases, diuretics are prescribed to reduce fluid overload and thereby control blood pressure. In clinical practice, diuretics are mostly prescribed based on clinical assessment of fluid status (e.g. hypertension, shortness of breath, edema). Less often biomarkers are used like brain natriuretic peptide and bio-impedance spectroscopy. Nevertheless, uncontrolled hypertension is highly prevalent in CKD patients, and leads to accelerated decline in kidney function as well as to cardiovascular disease. Bio-impedance spectroscopy is an accurate tool to assess fluid overload in CKD patients. Accurate assessment of fluid overload and appropriate prescription of diuretics are two pivotal factors to control blood pressure ultimately leading to preservation of kidney function in patients with CKD and decreased cardiovascular risk. Fluid overload in CKD is well documented, however, there are no randomized controlled trials demonstrating that strict fluid overload control in CKD patients improves blood pressure and outcome. Therefore, this study aims to reduce fluid overload in order to control blood pressure of hypertensive CKD patients using bio-impedance assessment of fluid status and using a diuretic therapy algorithm. First, fluid status will be assessed in all study participants using bio-impedance spectroscopy. Second, the study participants will be divided into two groups; the control group which will initially receive standard conventional therapy (no intervention) for 6 months. In the intervention group, the treatment regimen will be adjusted using bio-impedance spectroscopy and a treatment algorithm for diuretic therapy. Medications will be adjusted for 3 months and patients will be followed up for another 3 months. After 6 months, the control group will be subjected to the fluid overload management strategy. The primary outcomes of the current study are improvement in, a) fluid status towards normovolemia, and b) blood pressure toward normotension. Secondary outcome is improvement in vascular health as assessed by pulse wave velocity and augmentation index. Altogether, an optimized fluid status via a fluid management plan will provide better control of fluid overload, blood pressure, and improvement in vascular health in CKD patients.

Conditions
Hypertension
Being tested
Diuretic algorithm
Keywords
Fluid Overload, Vascular Stiffness, Chronic Kidney Disease
Medical subject headings
Hypertension, Edema, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diuretic algorithmOther

    Implementing diuretic algorithm

Study groups in NCT05378750
Study groupRoleWhat they receive
Intervention groupExperimentalBio-impedance spectroscopy. Treatment algorithm for diuretic therapy.
Receives: Other: Diuretic algorithm
Control groupNo interventionNo intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fluid status

    Decrease in fluid status measured using bio-impedance spectroscopy

    Measured: 12 months

  2. Blood pressure

    Decrease in blood pressure

    Measured: 12 months

Secondary outcomes (1)
  1. Vascular stiffness

    Improvement in vascular health as assessed by augmentation index.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2022
  2. Study start1 Nov 2022
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Why it stopped: Recruitment difficulties

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05378750
Sponsor's protocol ID
Pro00108113
Status last verified
Mar 2024
First submitted
1 Apr 2022
Last updated
28 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Diuretic algorithm in people with Hypertension, run by University of Alberta at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fluid status (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.

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