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Clinical Trials/NCT01380717
NCT01380717
Completed
Phase 4

The Role of Renal and Peripheral Vascular Resistance in Chronic Kidney Disease

University of Aarhus1 site in 1 country83 target enrollmentFebruary 2011

Overview

Phase
Phase 4
Intervention
Beta-blocker, ACE-inhibitor
Conditions
Chronic Kidney Insufficiency
Sponsor
University of Aarhus
Enrollment
83
Locations
1
Primary Endpoint
Change in glomerular filtration rate between the two treatment arms.
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2011
End Date
February 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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.

Arms & Interventions

Standard treatment

Patients with CKD 3-4, hypertension, treated for 18 months with beta-blocker and if needed ACE-inhibitor or ARB.

Intervention: Beta-blocker, ACE-inhibitor

Intensive vasodilation

Patients with CKD 3-4 and hypertension, randomized to treatment with calcium channel blocker and if needed ACE-inhibitor or ARB for 18 months

Intervention: Calcium Channel Blockers, ACE-Inhibitor

Outcomes

Primary Outcomes

Change in glomerular filtration rate between the two treatment arms.

Time Frame: Measured at baseline and after 18 months of treatment

Secondary Outcomes

  • 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)

Study Sites (1)

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