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.
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.
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 group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Bio-impedance spectroscopy.
Treatment algorithm for diuretic therapy. Receives: Other: Diuretic algorithm |
| Control group | No intervention | No intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid status
Decrease in fluid status measured using bio-impedance spectroscopy
Measured: 12 months
Blood pressure
Decrease in blood pressure
Measured: 12 months
Secondary outcomes (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.
- First posted18 May 2022
- Study start1 Nov 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Why it stopped: Recruitment difficulties
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 of AlbertaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluid Overload Management and Vascular Stiffness in Chronic Kidney Disease Patients With Hypertension
- ClinicalTrials.gov ID
- NCT05378750
- Acronym / sponsor ID
- Pro00108113
- Conditions
- Hypertension
- Keywords
- Fluid Overload, Vascular Stiffness, Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Diuretic algorithmBio-impedance spectroscopy. Treatment algorithm for diuretic therapy. |
| Control group | No intervention | –No intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diuretic algorithmImplementing diuretic algorithm | Other | Intervention group |
Primary outcome
Fluid status
Time frame: 12 months
Decrease in fluid status measured using bio-impedance spectroscopy
Blood pressure
Time frame: 12 months
Decrease in blood pressure
1 secondary outcome
Vascular stiffness
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.