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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01380717
First Posted: June 27, 2011
Last Update Posted: February 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Aarhus
  Purpose

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.


Condition Intervention Phase
Chronic Kidney Insufficiency Hypertension Vasodilation Drug: Beta-blocker, ACE-inhibitor Drug: Calcium Channel Blockers, ACE-Inhibitor Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Renal and Peripheral Vascular Resistance in Chronic Kidney Disease

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Change in glomerular filtration rate between the two treatment arms. [ Time Frame: Measured at baseline and after 18 months of treatment ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 18 months ]

Enrollment: 83
Study Start Date: February 2011
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard treatment
Patients with CKD 3-4, hypertension, treated for 18 months with beta-blocker and if needed ACE-inhibitor or ARB.
Drug: Beta-blocker, ACE-inhibitor
Beta-blocker: 50- 100 mg 1-2 times a day. ACEi: 5-10 mg once a day
Active Comparator: 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
Drug: Calcium Channel Blockers, ACE-Inhibitor
Calcium Channel Blockers: 5-10 mg a day. ACEi: 5-10 mg a day

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01380717


Locations
Denmark
Department of Renal Medicine, Aarhus University Hospital, Skejby
Aarhus N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Niels Henrik Buus, DrMedSc Department og Renal Medicine, Aarhus University Hospital, Skejby
  More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01380717     History of Changes
Other Study ID Numbers: RenVas
First Submitted: June 20, 2011
First Posted: June 27, 2011
Last Update Posted: February 27, 2014
Last Verified: September 2012

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Calcium, Dietary
Adrenergic beta-Antagonists
Angiotensin-Converting Enzyme Inhibitors
Calcium Channel Blockers
Bone Density Conservation Agents
Physiological Effects of Drugs
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Enzyme Inhibitors
Membrane Transport Modulators


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