- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00746070
Postoperative Cardiovascular Index Change of Primary Aldosteronism (TAIPAI)
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Aldosterone has rapid nongenomic effects in the human vasculature. Aldosterone has been claimed to lead to endothelial dysfunction, a condition related to development of cardiovascular disorders and to poor prognosis. However, studies of aldosterone effects on endothelial function led to discrepant findings, which may be related, at least in part, to inhomogeneity of the populations studied. Thus, studies in healthy subjects showed no detrimental effects of aldosterone on endothelial function and no positive effect of aldosterone inhibition, whereas populations with established cardiovascular diseases showed negative effects of aldosterone and positive effects of spironolactone therapy. Still, other factors may be of importance as effects of aldosterone on endothelial function are not homogenous even in a healthy population. Dosages of aldosterone, concomitant drug use, as well as the vascular bed investigated may influence the effects observed.
Furthermore, little is known about chronic endothelial effects of aldosterone that could indicate a primary and direct role of aldosterone in development of cardiovascular diseases. In patients with hyperaldosteronism diminished flow-mediated dilation was found, indicating impaired endothelial function compared with hypertensive patients without elevated aldosterone. However, it is not known whether these results represent endothelial dysfunction as the result of a direct aldosterone effect on the vasculature or a secondary effect attributable to more substantial hypertension.
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- aldosteronism with hyperaldosterone
- older than 18 year of age
- completed the informed consent
Exclusion Criteria:
- pregnancy
- bed-ridden
- could not do MRI
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
A, primary aldosteronism
patients approved to be aldosteronism
|
with the clinical observational study
|
B, essential hypertension
patients approved to be essential hypertension
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change of fibrosis and endothelium parameter
Tidsramme: post operation or taking spirolactone 4m, 12m
|
post operation or taking spirolactone 4m, 12m
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Cardiovascular events
Tidsramme: post operation or taking spirolactone for 5 years
|
post operation or taking spirolactone for 5 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studiestol: Yen-Hun Lin, MD, NTUH
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Chang HW, Chu TS, Huang HY, Chueh SC, Wu VC, Chen YM, Hsieh BS, Wu KD. Down-regulation of D2 dopamine receptor and increased protein kinase Cmu phosphorylation in aldosterone-producing adenoma play roles in aldosterone overproduction. J Clin Endocrinol Metab. 2007 May;92(5):1863-70. doi: 10.1210/jc.2006-2338. Epub 2007 Feb 13.
- Wu VC, Chueh SC, Chang HW, Lin WC, Liu KL, Li HY, Lin YH, Wu KD, Hsieh BS. Bilateral aldosterone-producing adenomas: differentiation from bilateral adrenal hyperplasia. QJM. 2008 Jan;101(1):13-22. doi: 10.1093/qjmed/hcm101.
- Chang HW, Wu VC, Huang CY, Huang HY, Chen YM, Chu TS, Wu KD, Hsieh BS. D4 dopamine receptor enhances angiotensin II-stimulated aldosterone secretion through PKC-epsilon and calcium signaling. Am J Physiol Endocrinol Metab. 2008 Mar;294(3):E622-9. doi: 10.1152/ajpendo.00657.2007. Epub 2008 Jan 2.
- Wu CH, Yang YW, Hung SC, Tsai YC, Hu YH, Lin YH, Chu TS, Wu KD, Wu VC. Effect of Treatment on Body Fluid in Patients with Unilateral Aldosterone Producing Adenoma: Adrenalectomy versus Spironolactone. Sci Rep. 2015 Oct 19;5:15297. doi: 10.1038/srep15297.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i det endokrine systemet
- Binyrebark hyperfunksjon
- Binyresykdommer
- Hyperaldosteronisme
- Fysiologiske effekter av legemidler
- Hormoner, hormonsubstitutter og hormonantagonister
- Natriuretiske midler
- Diuretika
- Hormonantagonister
- Mineralokortikoidreseptorantagonister
- Diuretika, Kaliumsparende
- Spironolakton
Andre studie-ID-numre
- 200611031R
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