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

Sponsor

Herlev Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00235287

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Chronic Cardiovascular Diseases	Drug: Candesartan and enalapril Drug: candesartan and enalapril Drug: candesartan and enalapril Drug: candesartan and enalapril	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease: An Interventional and Methodological Study

Study Start Date :

Sep 1, 2005

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

pulse wave velocity (aortic and brachial) [0, 8, 16 and 24 weeks after start of intervention]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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