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

NCT05378750 | Terminated

• 1 other identifier: Pro00108113
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Fluid Overload; Vascular Stiffness; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (2)

• Fluid status

  Decrease in fluid status measured using bio-impedance spectroscopy

  12 months

• Blood pressure

  Decrease in blood pressure

  12 months

Secondary Outcomes (1)

• Vascular stiffness

  12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Bio-impedance spectroscopy. Treatment algorithm for diuretic therapy.

Other: Diuretic algorithm

Control group

NO INTERVENTION

No intervention.

Interventions

Diuretic algorithm OTHER

Implementing diuretic algorithm

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2P4, Canada

Location

MeSH Terms

Conditions

Hypertension; Edema; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2022
• First Posted: May 18, 2022
• Study Start: November 1, 2022
• Primary Completion: November 1, 2023
• Study Completion: November 1, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

CA (1)