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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Kidney Insufficiency, Hypertension, Vasodilation

Intervention / Treatment
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* Drug: Beta-blocker, ACE-inhibitor
* Drug: Calcium Channel Blockers, ACE-Inhibitor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment<br>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<br>* Beta-blocker: 50- 100 mg 1-2 times a day. ACEi: 5-10 mg once a day<br>|
| Active Comparator: Intensive vasodilation<br>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<br>* Calcium Channel Blockers: 5-10 mg a day. ACEi: 5-10 mg a day<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 18 months |