Cardiac Allograft Vasculopathy Clinical Trial
Official title:
The Effect of Ivabradine Treatment on Exercise Capacity in Patients With Cardiac Allograft Vasculopathy After Heart Transplantation
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 rate at rest.
Patients will receive treatment with either ivabradin or placebo for a period of 12 weeks.
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 a negative predictor of outcome in heart
disease. The impact in heart transplant recipients is not fully understood, however, it has
been associated with increased risk of developing cardiac allograft vasculopathy (CAV) or
death.
Cardiac allograft vasculopathy is a diffuse vascular disease affecting the entire coronary
tree. It is the leading cause of death in patients more than 5 years after HTx and it is well
known that patients with CAV have markedly reduced exercise capacity.
The association between elevated HR and CAV raises the question whether an intervention to
specifically lower HR could improve symptoms and prognosis in heart transplant recipients
with CAV and elevated resting HR.
Small studies have shown that HR reduction using the If channel blocker ivabradine after HTx
is safe. However, none of these studies were randomized or blinded, and as such proof of any
efficacy (beyond HR reduction) after HTx is non-existing. Clearly, there is a need to
determine if such treatment could improve exercise capacity, graft function and prognosis
after HTx.
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