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

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT01380717

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

83 participants

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

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Feb 1, 2014

Actual Study Completion Date :

Feb 1, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in glomerular filtration rate between the two treatment arms. [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. [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.