Ignite Creation Date:
2024-05-06 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03619187
Status:
WITHDRAWN
Last Update Posted:
2018-11-19
First Post:
2018-08-02
Brief Title:
An Interventional Study to Evaluate the Effect of Ivabradine on Exercise Capacity in Heart Transplant Recipients
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Phase 3 Open-label Multicenter Study to Evaluate the Effect of Ivabradine on Exercise Capacity in Heart Transplant Recipients With Elevated Resting Heart Rate
Status:
WITHDRAWN
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor decision
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The hypothesis is that the treatment with ivabradine will increase pVO2 after 16 weeks of treatment compared to baseline in the heart transplant recipient population with elevated resting HR
Detailed Description:
The primary goal of this study is to assess the impact of ivabradine on cardiopulmonary exercise capacity in heart transplant recipients with elevated resting heart rate HR
Exercise capacity will be assessed by the determination of the peak oxygen consumption pVO2 during standard cardiopulmonary exercise test before and after the treatment period with ivabradine The secondary goal is to determine HR reduction with ivabradine in the patient population
Exercise capacity will be assessed by the determination of the peak oxygen consumption pVO2 during standard cardiopulmonary exercise test before and after the treatment period with ivabradine The secondary goal is to determine HR reduction with ivabradine in the patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None