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

February 26, 2014 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

83

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark, 8200
        • Department of Renal Medicine, Aarhus University Hospital, Skejby

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in glomerular filtration rate between the two treatment arms.
Time Frame: Measured at baseline and after 18 months of treatment
Measured at baseline and after 18 months of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Niels Henrik Buus, DrMedSc, Department og Renal Medicine, Aarhus University Hospital, Skejby

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

June 20, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

February 27, 2014

Last Update Submitted That Met QC Criteria

February 26, 2014

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RenVas

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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