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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Failure, Chronic Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A,AIIA

24 weeks of treatment with Candesartan, where Enalapril is added in the last 8 weeks.

Group Type ACTIVE_COMPARATOR

Candesartan and enalapril

Intervention Type DRUG

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.

A, ACE-I

24 weeks of treatment with Enalapril, where Candesartan is added in the last 8 weeks.

Group Type ACTIVE_COMPARATOR

candesartan and enalapril

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

candesartan and enalapril

Intervention Type DRUG

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.

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)

Group Type ACTIVE_COMPARATOR

candesartan and enalapril

Intervention Type DRUG

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)

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No