Status:
UNKNOWN
Effect of Ivabradine on Exercise Capacity After Heart Transplantation
Lead Sponsor:
Finn Gustafsson
Collaborating Sponsors:
Danish Heart Foundation
Rigshospitalet, Denmark
Conditions:
Cardiac Allograft Vasculopathy
Transplanted Heart Complication
Eligibility:
All Genders
18-100 years
Phase:
PHASE4
Brief Summary
This study evaluates whether treatment with ivabradine compared to placebo can improve exercise capacity in long-term heart transplant recipients with cardiac allograft vasculopathy and elevated heart...
Detailed Description
Elevated resting heart rate (HR) is a normal finding after successful heart transplantation (HTx) due to parasympathetic denervation at the operation. Elevated resting HR is generally acknowledged as...
Eligibility Criteria
Inclusion
- Patients \> 1 year post heart transplantation
- CAV verified by coronary angiography or intravascular ultrasound
- Resting HR \> 80 bpm
- Age \> 18 years
- Signed informed consent
- Women, who have not yet entered menopause (defined as no menstrual bleeding in the last 12 months), will be required to provide a negative urine human chorionic gonadotropin (hCG) before entering the study and must use a safe birth control method in the total study period.
Exclusion
- Rejection (\>H1R) \< 3 months
- Severe renal failure (estimated glomerular filtration rate (GFR) \< 30 mL/min/1.73 m2)
- Inability or contraindication to perform a VO2 max test
- Presence of any condition that might per se influence exercise performance
- Known contraindication for treatment with ivabradine
- Hypersensitivity to the active substance or to any of the excipients of either study drug
Key Trial Info
Start Date :
April 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT03405831
Start Date
April 17 2018
End Date
December 1 2019
Last Update
March 5 2019
Active Locations (1)
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1
Department of Cardiology, Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, DK-2100