Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease

Phase 4

• Conditions: Kidney Failure, Chronic; Cardiovascular Diseases
• Interventions: Drug: candesartan and enalapril

• Registration Number: NCT00235287
• Lead Sponsor: Herlev Hospital

Brief Summary

The purpose of this study is to determine whether a combination therapy with angiotensin-converting enzyme (ACE)-inhibitors and angiotensin receptor blockers reduces the arterial stiffness assessed by applantiontonometry more than a single treatment in kidney patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-10-06
• Study First Submitted QC: 2005-10-06
• Study First Posted: 2005-10-10
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-16
• Last Update Posted: 2009-01-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Creatinine: 150-350 micromol/L
• Blood pressure > 110 systolic
• Negative pregnancy test for fertile women
• Written and oral informed consent from the patient

Exclusion Criteria

• Treatment with both ACE-inhibitors (ACE-I) and angiotensin receptor blockers
• Pregnancy or breastfeeding
• Treatment with immunosuppressive medication, steroids or non-steroidal anti-inflammatory drugs (NSAIDs)
• Serious chronic heart failure (New York Heart Association [NYHA] III-IV)
• Chronic liver disease
• Suspicion or verified kidney artery stenosis
• Cardiac arrhythmia and/or implanted pacemaker
• Myocardial infarction or cerebrovascular incidence within the last 3 months
• Allergy towards ACE-I or angiotensin receptor blockers
• Amputation of a whole extremity or the crural or femoral part of the leg
• Dementia or a psychological condition that makes understanding of the examination conditions impossible
• Dialysis or renal transplantation
• Treatment with aldosterone antagonists
• Hyperkalemia > 5.5 mmol/l
• Another serious chronic non-renal disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A,AIIA	candesartan and enalapril	24 weeks of treatment with Candesartan, where Enalapril is added in the last 8 weeks.
A, ACE-I	candesartan and enalapril	24 weeks of treatment with Enalapril, where Candesartan is added in the last 8 weeks.
C, AIIA	candesartan and enalapril	8 weeks of treatment with Candesartan, followed by 8 weeks of treatment with Enalapril. The treatment in the last 8 out of the 24 weeks is a combination of Candesartan and Enalapril.
C, ACE	candesartan and enalapril	8 weeks of treatment with Enalapril in incremental doses (5,10,20 mg) , followed by 8 weeks of treatment with Candesartan in incremental doses (4,8,16 mg) . The treatment in the last 8 out of the 24 weeks is a combination of Candesartan 16 mg and Enalapril in incremental doses (5,10,20 mg)

Primary Outcome Measures

Name	Time	Method
pulse wave velocity (aortic and brachial)	0, 8, 16 and 24 weeks after start of intervention

Secondary Outcome Measures

Name	Time	Method
augmentation index	0, 8, 16 and 24 weeks after start of intervention
blood pressure (brachial and aortic)	0, 8, 16 and 24 weeks after start of intervention
buckbergs index	0, 8, 16 and 24 weeks after start of interven
time to reflection	0, 8, 16 and 24 weeks after start of interven
pulse pressure	0, 8, 16 and 24 weeks after start of interven
change in glomerular filtration rate (GFR)	0, 8, 16 and 24 weeks after start of interven
blood parameters	at start of intervention and after each 2.5 - 3.week in the study period

Trial Locations

Locations (1)

Dept. of Nephrology, Herlev University Hospital; 🇩🇰 Herlev, Denmark