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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00235287
• Date of registration: 06/10/2005
• Prospective Registration: No
• Primary sponsor: Herlev Hospital
• Public title: Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease
• Scientific title: Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease: An Interventional and Methodological Study
• Date of first enrolment: September 2005
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00235287
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Denmark

Contacts

• Name: Marie Frimodt-Møller, MD

• Name: Marie Frimodt-Møller, MD

• Name: Marie Frimodt-Møller, MD
• Affiliation: Dept. of Nephrology, Herlev University Hospital

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Cardiovascular Diseases

Kidney Failure, Chronic

Intervention(s)

Drug: Candesartan and enalapril

Primary Outcome(s)

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

Secondary Outcome(s)

blood pressure (brachial and aortic) [Time Frame: 0, 8, 16 and 24 weeks after start of intervention]

augmentation index [Time Frame: 0, 8, 16 and 24 weeks after start of intervention]

blood parameters [Time Frame: at start of intervention and after each 2.5 - 3.week in the study period]

change in glomerular filtration rate (GFR) [Time Frame: 0, 8, 16 and 24 weeks after start of interven]

buckbergs index [Time Frame: 0, 8, 16 and 24 weeks after start of interven]

pulse pressure [Time Frame: 0, 8, 16 and 24 weeks after start of interven]

time to reflection [Time Frame: 0, 8, 16 and 24 weeks after start of interven]

Secondary ID(s)

RAS-block study

Source(s) of Monetary Support

Please refer to primary and secondary sponsors