Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease: An Interventional and Methodological Study
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Herlev Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- pulse wave velocity (aortic and brachial)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
A,AIIA
24 weeks of treatment with Candesartan, where Enalapril is added in the last 8 weeks.
Intervention: candesartan and enalapril (Drug)
A, ACE-I
24 weeks of treatment with Enalapril, where Candesartan is added in the last 8 weeks.
Intervention: candesartan and enalapril (Drug)
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.
Intervention: candesartan and enalapril (Drug)
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)
Intervention: candesartan and enalapril (Drug)
Outcomes
Primary Outcomes
pulse wave velocity (aortic and brachial)
Time Frame: 0, 8, 16 and 24 weeks after start of intervention
Secondary Outcomes
- 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)