- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00746070
Postoperative Cardiovascular Index Change of Primary Aldosteronism (TAIPAI)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
A, primary aldosteronism
patients approved to be aldosteronism
|
with the clinical observational study
|
B, essential hypertension
patients approved to be essential hypertension
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Change of fibrosis and endothelium parameter
Tidsram: post operation or taking spirolactone 4m, 12m
|
post operation or taking spirolactone 4m, 12m
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
Cardiovascular events
Tidsram: post operation or taking spirolactone for 5 years
|
post operation or taking spirolactone for 5 years
|
Samarbetspartners och utredare
Utredare
- Studiestol: Yen-Hun Lin, MD, NTUH
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Binjurebark hyperfunktion
- Adrenal Gland Sjukdomar
- Hyperaldosteronism
- Läkemedels fysiologiska effekter
- Hormoner, hormonsubstitut och hormonantagonister
- Natriuretiska medel
- Diuretika
- Hormonantagonister
- Mineralokortikoidreceptorantagonister
- Diuretika, Kaliumsparande
- Spironolakton
Andra studie-ID-nummer
- 200611031R
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Kliniska prövningar på Aldosteronism
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Centre Integre Universitaire de Sante et Services...Har inte rekryterat ännu
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Chongqing Medical UniversityChinese PLA General Hospital; Tianjin Medical University General Hospital; Chinese Academy of Medical Sciences, Fuwai HospitalRekrytering
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Chongqing Medical UniversityRekrytering
-
Shanghai Jiao Tong University School of MedicineHar inte rekryterat ännu
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Chongqing Medical UniversityRekrytering
-
Damian Pharma AGAvslutad
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University of CambridgeCambridge University Hospitals NHS Foundation TrustOkänd
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University Hospital, Basel, SwitzerlandAvslutad
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International Islamic University MalaysiaUniversity of Malaya; National University of Malaysia; International Medical... och andra samarbetspartnersOkändPrimär aldosteronism
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National Taiwan University HospitalNovartisOkänd