Ignite Creation Date:
2024-05-06 @ 7:42 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02584439
Status:
UNKNOWN
Last Update Posted:
2016-12-07
First Post:
2015-10-21
Brief Title:
Effect of Pharmacological Heart Rate Reduction on Visco-elastic Properties of the Arterial Wall BRADYVASC
Sponsor:
University Hospital Rouen
Organization:
University Hospital Rouen
Study Overview
Official Title:
Effect of Pharmacological Heart Rate Reduction on Visco-elastic Properties of the Arterial Wall BRADYVASC
Status:
UNKNOWN
Status Verified Date:
2016-12
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:
BRADYVASC
Brief Summary:
The conduit arteries exhibit a viscoelastic behavior Visco-elasticity is partially regulated by endothelium and contributes to the optimization of the heart-vessel coupling Aging or high resting heart rate HR could alter visco-elastic properties leading to increase stiffness of the conduit arteries an independent cardiovascular risk factor and degradation of heart-vessel coupling Lowering HR with ivabradine could reduce these effects
The objective of this study is to assess the effect of HR reduction by repeated administration of ivabradine on visco-elastic properties vascular geometry and function of common carotid artery and on cardiovascular hemodynamic in healthy subject The influence of aging on ivabradine effects are studied too
30 healthy volunteers aged between 25 and 65 years old with a HR 70 bpm will receive ivabradine or placebo during 8 days in a single center randomized cross-group double blinded placebo-controlled study Each period of treatment will be separate by 12 to 16 days of wash-out Each subject will participate in an exploration visit including evaluation of visco-elastic properties vascular geometry and function of common carotid artery and cardiovascular hemodynamic before and after ivabradine or placebo taking
The objective of this study is to assess the effect of HR reduction by repeated administration of ivabradine on visco-elastic properties vascular geometry and function of common carotid artery and on cardiovascular hemodynamic in healthy subject The influence of aging on ivabradine effects are studied too
30 healthy volunteers aged between 25 and 65 years old with a HR 70 bpm will receive ivabradine or placebo during 8 days in a single center randomized cross-group double blinded placebo-controlled study Each period of treatment will be separate by 12 to 16 days of wash-out Each subject will participate in an exploration visit including evaluation of visco-elastic properties vascular geometry and function of common carotid artery and cardiovascular hemodynamic before and after ivabradine or placebo taking
Detailed Description:
None
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 |
|---|---|---|---|
| 2015-002060-17 | EUDRACT_NUMBER | None | None |