A threshold reduction in LDL-C is required to improve endothelial function as measured by the flow mediated dilation (FMD).
ID
Bron
Verkorte titel
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The effect of various doses of simvastatin (5-40 mg) on endothelial function as measured by flow mediated dilatation (FMD) compared to placebo.
Achtergrond van het onderzoek
In 40 young adults with FH we will examine the effect of various dosis simvastatin (0-5-10-20-40 mg/day during 8 weeks) on the endothelial function. This will reveal whether a threshold exists for an LDL-C reduction required to improve FMD.
Doel van het onderzoek
A threshold reduction in LDL-C is required to improve endothelial function as measured by the flow mediated dilation (FMD).
Onderzoeksproduct en/of interventie
Various doses of simvastatin (0-5-10-20-40 mg/day during 8 weeks), compared to placebo.
Publiek
P.O. Box 22660
M.D. Trip
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665882 or 020-5669111
m.d.trip@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
M.D. Trip
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5665882 or 020-5669111
m.d.trip@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Healthy heterozygous FH patients aged >18 years with a documented LDL receptor mutation and LDL cholesterol level above the 95th percentile for age and gender. Or LDL cholesterol above 95st percentile and a positive family history for FH or premature CAD.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Females who are pregnant or intend to become pregnant; hypersensitivity or contraidication to simvastatin; excessive alcohol consumption, smoking or drug abuse.
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL490 |
| NTR-old | NTR532 |
| Ander register | : N/A |
| ISRCTN | ISRCTN47683043 |