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

Herlev Hospital

Status and phase: Unknown; Phase 4

Conditions: Cardiovascular Diseases; Kidney Failure, Chronic

Treatments: Drug: candesartan and enalapril; Drug: Candesartan and enalapril

Study type: Interventional

Funder types: Other

Identifiers

NCT00235287

RAS-block study

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

A,AIIA

Active Comparator group

Description:

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

Treatment:

Drug: Candesartan and enalapril

A, ACE-I

Active Comparator group

Description:

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

Treatment:

Drug: candesartan and enalapril

Drug: candesartan and enalapril

Drug: candesartan and enalapril

C, AIIA

Active Comparator group

Description:

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.

Treatment:

Drug: candesartan and enalapril

Drug: candesartan and enalapril

Drug: candesartan and enalapril

C, ACE

Active Comparator group

Description:

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)

Treatment:

Drug: candesartan and enalapril

Drug: candesartan and enalapril

Drug: candesartan and enalapril