This trial is active, not recruiting.

Condition heart transplant recipients
Sponsor Oslo University Hospital
Collaborator South-Eastern Norway Regional Health Authority
Start date January 2013
End date March 2016
Trial size 100 participants
Trial identifier NCT01759966, 2012/1428


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Patients receiving orthotopic heart transplant in the enrollment period
Healthy control subjects, having the same age and sex distribution as the heart transplant recipients

Primary Outcomes

Cardiac allograft vasculopathy
time frame: 1 year
Acute rejections
time frame: 1 year

Secondary Outcomes

Cardiac allograft vasculopathy
time frame: 3 years
Acute rejections
time frame: 2 and 3 years
Autonomic cardiovascular responses
time frame: 6 months, 1, 2 and 3 years
Exercise capacity
time frame: 1, 2 and 3 years
Activity recordings
time frame: 6 months, 1, 2 and 3 years
Hormonal levels
time frame: 6 months, 1, 2 and 3 years
General immune activity
time frame: 6 months, 1, 2 and 3 years
Pain threshold
time frame: 6 months, 1, 2 and 3 years
Clinical symptoms
time frame: 6 months, 1, 2 and 3 years
time frame: 1 and 3 years
Echocardiographic indices
time frame: 1, 2 and 3 years
Ambulant blood pressure recording
time frame: 1, 2 and 3 years
Cardiac catheterization
time frame: 1, 2 and 3 years

Eligibility Criteria

Male or female participants from 17 years up to 69 years old.

Inclusion Criteria HTRs: - Completed heart transplantation during the last 7-12 weeks - Age > 16 years and < 70 years Exclusion criteria HTRs: - Peri- or postoperative complications causing permanent dysfunction of the allograft (such as hyperacute rejection episodes, severe myocardial ischemia, etc.) - Diabetes with HbA1C > 6,5 % and/or manifest diabetic complications - Renal failure with plasma creatinine > 200 µmol/L - ECG abnormalities (scattered ectopic beats ad minor conduction problems are allowed) - Permanently bed-ridden Inclusion criteria healthy controls: - Age and gender matching the HTRs Exclusion criteria healthy controls: - Another chronic disease (such as diabetes mellitus) - Permanent use of pharmaceuticals (including hormone drugs) - Pregnancy

Additional Information

Official title Autonomic Cardiovascular Control After Heart Transplantation
Principal investigator Vegard B Wyller, MD,PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Oslo University Hospital.