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

Primary Purpose

Hypertension

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Diuretic algorithm
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Fluid Overload, Vascular Stiffness, Chronic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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).

Sites / Locations

  • University of AlbertaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

Bio-impedance spectroscopy. Treatment algorithm for diuretic therapy.

No intervention.

Outcomes

Primary Outcome Measures

Fluid status
Decrease in fluid status measured using bio-impedance spectroscopy
Blood pressure
Decrease in blood pressure

Secondary Outcome Measures

Vascular stiffness
Improvement in vascular health as assessed by augmentation index.

Full Information

First Posted
April 1, 2022
Last Updated
June 30, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT05378750
Brief Title
Fluid Overload Management and Vascular Stiffness in Chronic Kidney Disease Patients With Hypertension
Official Title
Fluid Overload Management and Vascular Stiffness in Chronic Kidney Disease Patients With Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
July 7, 2024 (Anticipated)
Study Completion Date
July 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Fluid Overload, Vascular Stiffness, Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
172 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Bio-impedance spectroscopy. Treatment algorithm for diuretic therapy.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention.
Intervention Type
Other
Intervention Name(s)
Diuretic algorithm
Intervention Description
Implementing diuretic algorithm
Primary Outcome Measure Information:
Title
Fluid status
Description
Decrease in fluid status measured using bio-impedance spectroscopy
Time Frame
12 months
Title
Blood pressure
Description
Decrease in blood pressure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Vascular stiffness
Description
Improvement in vascular health as assessed by augmentation index.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Branko Braam, MD PhD
Phone
+1 7804921867
Email
Braam@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Aya Lafta, Msc
Phone
+1 7804921867
Email
lafta@ualberta.ca
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2P4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Branko Braam, MD PhD
Email
Braam@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Aya Lafta, MSc
Email
lafta@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Branko Braam, MD PhD
First Name & Middle Initial & Last Name & Degree
Aya Lafta, MSc
First Name & Middle Initial & Last Name & Degree
Aminu Bello, MD PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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