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Diuretic
Guided Diuretic Therapy for High Blood Pressure in Chronic Kidney Disease
N/A
Waitlist Available
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult (>18 years old) outpatient with uncontrolled hypertension; defined as, AMBP ≥ 130/80 mmHg despite treatment
Fluid overload of more than 5% of estimated normal ECFV, as assessed by Bio-impedance spectroscopy (using the Body Composition Monitor, a validated device marketed by Fresenius, Canada)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing whether using a patient's bio-impedance to guide diuretic therapy can help control blood pressure in people with hypertensive CKD.
Who is the study for?
This trial is for adults over 18 with uncontrolled high blood pressure and moderate chronic kidney disease, who have fluid overload. They must not be pregnant or breastfeeding, should be able to give consent, and not have had recent surgery or severe conditions like heart failure or cancer.Check my eligibility
What is being tested?
The study tests a diuretic therapy algorithm designed to manage fluid overload in hypertensive patients with chronic kidney disease by using bio-impedance to assess their fluid status.See study design
What are the potential side effects?
Potential side effects may include dehydration, electrolyte imbalances (like low potassium), increased urination, dizziness, headaches, and possibly allergic reactions to the diuretics used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult with high blood pressure not controlled by medication.
Select...
My body has more than 5% excess fluid compared to what's normal, confirmed by a special body fluid test.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blood pressure
Fluid status
Secondary outcome measures
Vascular stiffness
Side effects data
From 2019 Phase 2 trial • 130 Patients • NCT031361988%
NSTEMI type 2
6%
Acute Kidney Injury
3%
Respiratory failure
2%
Bradycardia
2%
Mural thrombus
2%
Nonsustained ventricular tachycardia
2%
Hypotension
2%
NSTEMI
2%
Iron deficiency anemia
2%
MGUS, new diagnosis
2%
Hyperkalemia
2%
Urinary retention
2%
Proteinuria
2%
Pulmonary embolism
2%
Mitral Regurgitation, severe
2%
Mitral valve disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Usual Care
LUS-guided Strategy-of-care
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
Bio-impedance spectroscopy.
Treatment algorithm for diuretic therapy.
Group II: Control groupActive Control1 Intervention
No intervention.
Find a Location
Who is running the clinical trial?
University of AlbertaLead Sponsor
886 Previous Clinical Trials
384,826 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
- Group 2: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still available enrollment in this clinical investigation?
"The information hosted on clinicaltrials.gov suggests that this particular trial is not currently enrolling patients; it was posted on November 1st 2022 and last edited October 18th 2022. Conversely, 1216 other studies are actively recruiting right now so there may be opportunities to participate in medical research elsewhere."
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