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Clinical Trial Summary

The purpose of this prospective study is to investigate denervation (ie. surgical cutting of autonomic nerves) and re-innervation (ie. growth of autonomic nerves) in heart transplant recipients. More specifically, we focus on:

1. The physiological consequences of denervation, in particular its consequences for clinical symptoms, orthostatic tolerance (ie. the ability to stand upright) and exercise capacity. We hypothesize that denervation has negative consequences for all these factors.

2. The pathological consequences of denervation and reinnervation, in particular its association to acute rejection and coronary artery disease (cardiac allograft vasculopathy, CAV). We hypothesize that reinnervation protects against acute rejection and development of CAV

3. Donor and recipient factors associated with the reinnervation process. We hypothesize that characteristics of the surgical procedure (such as aorta cross-clamp time) as well as the rehabilitation process of the recipient (such as physical activity) impacts on the reinnervation process.


Clinical Trial Description

Heart transplantation is annually offered to more than 3500 patients worldwide. In Norway, the number is approximately 30/year, and all transplants are carried out at one single hospital (Oslo University Hospital, Rikshospitalet).

Normally, the heart function is intimately controlled by the autonomic nervous system (ANS), but all nervous connections are lost during the surgical transplantation procedure, and the transplanted heart thus becomes denervated. In time, regrowth of nerves may cause partial reinnervation of the new heart.

Some evidence suggests that reinnervation improves exercise capacity and reduces episodes of acute rejections and the development of cardiac allograft vasculopathy. The purpose of this study is further to investigate the changes over time with respect to all parts of the autonomic nervous system (the sympathetic, parasympathetic and sensoric part), and the associated physiological and pathological consequences.

The study may provide knowledge which ultimately could help us improve health and quality of live for heart transplant recipients. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01759966
Study type Observational
Source Oslo University Hospital
Contact
Status Active, not recruiting
Phase
Start date January 2013
Completion date December 2019

See also
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Completed NCT01914406 - High-intensity Interval Training Versus Moderate Continuous Training in Heart Transplant Recipients. N/A
Completed NCT01796379 - High Intensity Training in de Novo Heart Transplant Recipients in Scandinavia N/A
Completed NCT02213770 - Long Term Effect of High-intensity Training After Heart Transplantation N/A
Completed NCT03662789 - Intravenous Iron Supplement for Iron Deficiency in Cardiac Transplant Recipients Phase 2/Phase 3