Renal and Systemic Vascular Resistance in Chronic Kidney Disease (CKD)

Phase 4

Completed

• Conditions: Chronic Kidney Insufficiency; Hypertension; Vasodilation
• Interventions: Drug: Beta-blocker, ACE-inhibitor; Drug: Calcium Channel Blockers, ACE-Inhibitor

• Registration Number: NCT01380717
• Lead Sponsor: University of Aarhus

Brief Summary

Patients with reduced kidney function have a higher risk of heart disease and death. Studies have shown that blood vessels in patients with hypertension change with a decrease of lumen size and growth of the vessel wall. By treating patients with antihypertensive certain medication vessel lumen and walls normalize. Treating hypertension in patients with chronic kidney disease slows the progression of kidney function loss.

The aim is to compare different degrees of antihypertensive medication in patients with chronic kidney disease and hypertension will slow the progression of kidney loss.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-06-20
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Status Verified: 2012-09
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• eGFR 15-60 ml/min for at least 3 months
• Blood pressure > 130 mmHg systolic og >80 mmHg diastolic (patients without antihypertensive treatment or in treatment with Beta-blockers, ACEi, ARBs or CCB not in maximum dosi).
• Blood pressure < 130 mmHg systolic og < 80 mmHg diastolic (patients receiving Beta-blockers, ACEi, ARBs og CCB).
• Fertile women using safe contraceptives

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Exclusion Criteria

• Ultrasound verified Polycystic Kidney Disease (ADPKD)
• Claustrophobia (MRi scan).
• Contraindications to MRi.
• Pregnancy or wish to become pregnant in the study period.
• Nephrotic syndrome with gross edema.
• Known allergy to any study medication.
• Blood pressure < 130 mmHg systolic or < 80 mmHg diastolic without antihypertensive treatment.
• Blood pressure > 130 mmHg systolic or > 80 mmHg diastolic and in maximum dosages of all three Beta-blockers, ACEi (ARBs) and CCB.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment	Beta-blocker, ACE-inhibitor	Patients with CKD 3-4, hypertension, treated for 18 months with beta-blocker and if needed ACE-inhibitor or ARB.
Intensive vasodilation	Calcium Channel Blockers, ACE-Inhibitor	Patients with CKD 3-4 and hypertension, randomized to treatment with calcium channel blocker and if needed ACE-inhibitor or ARB for 18 months

Primary Outcome Measures

Name	Time	Method
Change in glomerular filtration rate between the two treatment arms.	Measured at baseline and after 18 months of treatment

Secondary Outcome Measures

Name	Time	Method
Changes in glomerular filtration rate stratified after changes in pulse wave velocity, renal vascular resistance and forearm minimal resistance at baseline and after 18 months of treatment.	18 months

Trial Locations

Locations (1)

Department of Renal Medicine, Aarhus University Hospital, Skejby; 🇩🇰 Aarhus N, Denmark