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ADMA and renal endothelial dysfunction


- candidate number3970
- NTR NumberNTR1443
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-sep-2008
- Secondary IDs 
- Public TitleADMA and renal endothelial dysfunction
- Scientific TitleADMA and renal endothelial dysfunction: the effects of ARB and/or statins in hypertensive patients with mild renal insufficiency
- ACRONYMN/A
- hypothesisADMA (asymmetric dimethylarginine) plasma concentrations are higher in persons with mild renal insufficiency compared to persons with normal kidney function. ADMA plasma concentrations are inversely proportional to renal perfusion and endothelial nitric oxide (NO) availibility in the kidney. Medical treatment with statins and/or angiotensin II receptor blockers (ARB) will reduce ADMA plasma concentrations, improves kidney perfusion and NO availibility.
- Healt Condition(s) or Problem(s) studiedRenal insufficiency, Hypertension, Methylenedioxymethamphetamine (MDMA)
- Inclusion criteria1. Hypertension (Office blood pressure: >140 and/or >90 mmHg or mean ABPM blood pressure: >125 and/or >80 mmHg)
2. Age: 18-75 jaar
3. Creatinin clearance of 60-90 mL/min (Cockcroft-Gault formule)
4. Renal angiography indicated based on the following criteria:
- Refractory hypertension
- Accelerating or malignant hypertension - Elevating serum creatinin after an ACE-inhibitor or ARB
- Kidney size < 8 cm measured by ultrasound
- Unexplained hypokalemia
- Abdominal or renal souffle
- Manifestations of atherosclerosis elsewhere
- “Flash” oedema
- Exclusion criteria1. Primary kidney diseases or urological complaints
2. Diabetes Mellitus
3. Chronic inflammatory diseases
4. Recent infections (< 3 weeks)
5. Unilateral or bilateral renal artery stenosis
6. Fibromuscular dysplasia
7. Contraindication for ARB or statin
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2008
- planned closingdate1-okt-2009
- Target number of participants45
- Interventions- 3 weeks treatment with ARB and/or statin
- Intrarenal L-NMMA (monomethyl-L arginine, NO synthase inhibitor) infusion
- Primary outcomeo Basal renal perfusion measured
o Fractional change in renal perfusion after intrarenal L-NMMA infusion
o Arterial en venous ADMA, SDMA (symmetric dimethylarginine) and L-arginine concentrations
o Renal elimination of systemic ADMA, SDMA and L-arginine
- Secondary outcomeo Microalbuminuria (24-hour urine collection)
o Creatinin clearance (24-hour urine collection)
o Blood pressure
o Plasma LDL (low density lipoproteins), HDL (high density lipoproteins), triglycerides and total cholesterol concentrations
- Timepoints- 3 weeks before renal angiography --> start medication treatment
- after 3 weeks treatment --> renal angiography with additional measurements
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. R.A. Ronden
- CONTACT for SCIENTIFIC QUERIESdr. A.A. Kroon
- Sponsor/Initiator University Hospital Maastricht (AZM), Department of Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
Dutch Heart Foundation (Nederlandse Hartstichting)
- PublicationsN/A
- Brief summary
- Main changes (audit trail)
- RECORD11-sep-2008 - 18-sep-2008


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