Ignite Creation Date:
2024-05-05 @ 10:14 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01069042
Status:
UNKNOWN
Last Update Posted:
2010-02-25
First Post:
2010-02-12
Brief Title:
Anti-Hypertensive Agent ACEi and Heart Function Improvement in Association With Rho Kinase Activity Changes in Human
Sponsor:
National Cheng-Kung University Hospital
Organization:
National Cheng-Kung University Hospital
Study Overview
Official Title:
A Clinical Study on Anti-Hypertensive Agent ACEi and Heart Function Improvement
Status:
UNKNOWN
Status Verified Date:
2010-02
Last Known Status:
RECRUITING
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:
Hypothesis Rho one of the small GTPase proteins and its downstream target molecule Rho-kinase ROCK play important roles in mediating various cellular functions including contractility actin cytoskeleton organization cell adhesion and motility proliferation cytokinesis and gene expressions all of which are involved in the pathogenesis of cardiomyocyte contractility and other vascular disease The investigators thus hypothesize that ROCK pathway plays an important role in the function and severity of heart failure HF and can be one of the possible pathway that currently applied cardiovascular medicine affecting their prognosis among HF treatment
Previous study has shown that in patients with HF intra-arterial infusion of fasudil causes preferential increase in forearm blood flow as compared with control subjects suggesting an involvement of RhoRho-kinase pathway in the increased peripheral vascular HF failure remain to be examined Besides whether the rho kinase activity was enhanced or their response to current medication in HF patients remained unsolved
Aim ROCK activity and left ventricular function between HF or non-HF population survey and their response to ACEi Tx
Previous study has shown that in patients with HF intra-arterial infusion of fasudil causes preferential increase in forearm blood flow as compared with control subjects suggesting an involvement of RhoRho-kinase pathway in the increased peripheral vascular HF failure remain to be examined Besides whether the rho kinase activity was enhanced or their response to current medication in HF patients remained unsolved
Aim ROCK activity and left ventricular function between HF or non-HF population survey and their response to ACEi Tx
Detailed Description:
Study design We will enroll subjects from clinics of National Cheng Kung University Hospital
Subjects will be then divided to two groups by their left ventricular ejection fraction LVEF ratio preserved LVEF EF40 and impaired LVEF EF40 All subjects will initially receive 10mg of enalapril and be gradually titrated up to 20mg with blood pressure tolerance for 6 months Before and after 6 months echocardiography and blood sample will be assayed for biomarkers and rho kinase activity respectively
Outcomes and measurement The outcomes will include the mean changes in the Rho-kinase activity in leukocytes before and after periods of treatment Leukocyte Rho-kinase expression and activity will be measured in cells isolated from peripheral blood samples and frozen at -80 C The other outcomes are the correlation between the mean changes in Rho-kinase activity in leukocytes and cardiac function measured by 2D and M-mode echocardiography In addition we will calculate the association of ROCK activity and B-type natriuretic peptide BNP high sensitivity C-reactive protein hsCRP as well as its relation with clinical characteristics The demographic relevant clinical data and laboratory results will be all collected from patients andor medical records
Primary Outcomes and measurement The primary outcomes are the mean changes in the Rho-kinase activity in leukocytes before and after periods of treatment Leukocyte Rho-kinase expression and activity will be measured in cells isolated from peripheral blood samples and frozen at -80 C Western Blot assays will be performed to measure Rho-kinase activity
Secondary Outcomes and measurement The secondary outcomes are the correlation between the mean changes in Rho-kinase activity in leukocytes and cardiac function measured by echocardiography and tissue Doppler to measure systolic and diastolic function In addition the association of Rho kinase activity and BNP hsCRP as well as its relation with clinical characteristics will be measured
Besides we will check the renal and liver function deterioration changes in serum potassium levels need for kidney replacement therapy and postural hypotension or dizziness or shock events to monitor the safety issues Other parameters of adding medication will be recorded including side effects like cough angioedema skin rash intolerance to the medication
Subjects will be then divided to two groups by their left ventricular ejection fraction LVEF ratio preserved LVEF EF40 and impaired LVEF EF40 All subjects will initially receive 10mg of enalapril and be gradually titrated up to 20mg with blood pressure tolerance for 6 months Before and after 6 months echocardiography and blood sample will be assayed for biomarkers and rho kinase activity respectively
Outcomes and measurement The outcomes will include the mean changes in the Rho-kinase activity in leukocytes before and after periods of treatment Leukocyte Rho-kinase expression and activity will be measured in cells isolated from peripheral blood samples and frozen at -80 C The other outcomes are the correlation between the mean changes in Rho-kinase activity in leukocytes and cardiac function measured by 2D and M-mode echocardiography In addition we will calculate the association of ROCK activity and B-type natriuretic peptide BNP high sensitivity C-reactive protein hsCRP as well as its relation with clinical characteristics The demographic relevant clinical data and laboratory results will be all collected from patients andor medical records
Primary Outcomes and measurement The primary outcomes are the mean changes in the Rho-kinase activity in leukocytes before and after periods of treatment Leukocyte Rho-kinase expression and activity will be measured in cells isolated from peripheral blood samples and frozen at -80 C Western Blot assays will be performed to measure Rho-kinase activity
Secondary Outcomes and measurement The secondary outcomes are the correlation between the mean changes in Rho-kinase activity in leukocytes and cardiac function measured by echocardiography and tissue Doppler to measure systolic and diastolic function In addition the association of Rho kinase activity and BNP hsCRP as well as its relation with clinical characteristics will be measured
Besides we will check the renal and liver function deterioration changes in serum potassium levels need for kidney replacement therapy and postural hypotension or dizziness or shock events to monitor the safety issues Other parameters of adding medication will be recorded including side effects like cough angioedema skin rash intolerance to the medication
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