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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01380717
First received: June 20, 2011
Last updated: February 26, 2014
Last verified: September 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01380717     History of Changes
Other Study ID Numbers: RenVas
Study First Received: June 20, 2011
Last Updated: February 26, 2014
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Additional relevant MeSH terms:
Hypertension
Renal Insufficiency, Chronic
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Adrenergic beta-Antagonists
Calcium Channel Blockers
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Membrane Transport Modulators
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014