Ignite Creation Date:
2024-05-05 @ 11:41 PM
Last Modification Date:
2024-10-26 @ 10:38 AM
Study NCT ID:
NCT01392638
Status:
COMPLETED
Last Update Posted:
2012-10-30
First Post:
2011-01-25
Brief Title:
Effects of Sildenafil in Resistant Hypertensives and Genetic Polymorphism
Sponsor:
University of Campinas Brazil
Organization:
University of Campinas Brazil
Study Overview
Official Title:
Influence of the Nitric Oxide Synthase T-786C Polymorphism on the Response to Acute Inhibition of Phosphodiesterase 5 in Resistant Hypertension
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sildenafil citrate slightly reduces blood pressure in treated hypertensives patients However it is unknown if the simultaneous use of sildenafil plus at least 3 classes of antihypertensive agents in patients with resistant arterial hypertension may have a synergic effect on the patients blood pressure Moreover sildenafil improves the endogen nitric oxide effects The nitric oxide is an important signaling molecule in the body that contributes to vessel homeostasis by inhibiting vascular smooth muscle contraction and growth Hypertension often impaired NO pathways Nitric oxide is produced by an enzyme called nitric oxide synthase NOS3 that show some genetics variants which means that this enzyme can be different from person to person Therefore the objective of the present study is to examine the influence of a genetic variant known to affect NOS3 levels in sildenafil acute effects on hemodynamic and cardiovascular function The investigators hypothesis is that individuals with the genetic variant associated to higher levels of NOS3 will have more benefits from sildenafil treatment
Detailed Description:
Endothelial dysfunction is one of the mechanisms involved in the maintenance of the high blood pressure levels in resistants hypertensives patients which is directly related to the NO-GMPc pathway The phosphodiesterase 5 inhibitor sildenafil citrate slightly reduces systolic and diastolic blood pressures in treated hypertensives patients However it is unknown if the simultaneous use of sildenafil plus at least 3 classes of antihypertensive agents in patients with resistant arterial hypertension may have a synergic effect on the patients blood pressure Moreover sildenafil improves the endogen nitric oxide effects produced by eNOS Therefore since the genetics polymorphisms of eNOS can affect the NO tissue levels it seems reasonable to suppose that the acute effects of sildenafil may be modulated by them Objective To examine the influence of the T-786C polymorphism of eNOS gene in sildenafil acute effects on hemodynamic and cardiovascular function in resistant hypertensives patients Casuistics and Methods Around 120 patients with HAR will be genotyped for the T-786C eNOS polymorphism from which the investigators will enroll in this study 15 patients with TT genotype and 15 patients with CC genotype The patients will be monitored with the Portapres system non-invasive hemodynamic After basal records of the studied variables increasing doses of sildenafil will be administrated 375 500 e 1000 mg Five minutes before each new dose the studied variables will be recorded again Hypothesis The investigators hypothesize that the sildenafil besides the anti-ischemic effect will improve the patients hemodynamic status and moreover that it will occur a modulation of this effect by the T-786C polymorphism
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FAPESP | OTHER | 200913774-9 | None |