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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00235287
• Other study ID #: RAS-block study
• Status: Recruiting
• Phase: Phase 4
• First received: October 6, 2005
• Last updated: January 16, 2009
• Start date: September 2005

Study information

• Verified date: January 2009
• Source: Herlev Hospital
• Contact: Marie Frimodt-Møller, MD
• Phone: + 45 44 88 44 88
• Email: marfri01[@]heh.regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

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.
• 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.
• 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.
• 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)

Locations

Country	Name	City	State
Denmark	Dept. of Nephrology, Herlev University Hospital	Herlev

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulse wave velocity (aortic and brachial)		0, 8, 16 and 24 weeks after start of intervention	No
Secondary	augmentation index		0, 8, 16 and 24 weeks after start of intervention	No
Secondary	blood pressure (brachial and aortic)		0, 8, 16 and 24 weeks after start of intervention	No
Secondary	buckbergs index		0, 8, 16 and 24 weeks after start of interven	No
Secondary	time to reflection		0, 8, 16 and 24 weeks after start of interven	No
Secondary	pulse pressure		0, 8, 16 and 24 weeks after start of interven	No
Secondary	change in glomerular filtration rate (GFR)		0, 8, 16 and 24 weeks after start of interven	No
Secondary	blood parameters		at start of intervention and after each 2.5 - 3.week in the study period	Yes