NCT03619187

An Interventional Study to Evaluate the Effect of Ivabradine on Exercise Capacity in Heart Transplant Recipients

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• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Heart Transplantation, Elevated Resting Heart Rate

Interventions

Type	Name	Description
DRUG	Ivabradine	Ivabradine will be provided in bottles (60 tablets per bottle) labeled ivabradine 5 mg and ivabradine 7.5 mg. The 2.5 mg dose of ivabradine will be achieved by subjects splitting the 5 mg tablets into equal halves.

Timeline

• Start date: 2018-11-02
• Primary completion: 2020-02-19
• Completion: 2020-02-19
• First posted: 2018-08-07
• Last updated: 2018-11-19

Regulatory

• FDA-regulated drug study