This trial is active, not recruiting.

Condition cardiac allograft vasculopathy
Treatment blood samples
Sponsor Assistance Publique Hopitaux De Marseille
Start date February 2011
End date May 2014
Trial size 170 participants
Trial identifier NCT01569334, 2010 18, 2010-A01145-34


Heart transplantation is the best option for patients with end-stage heart failure. Cardiac allograft vasculopathy (CAV) is the leading cause of death following cardiac transplantation and is not managed by current therapies. Its pathogenesis traduces in an accelerated form of coronary artery disease (CAD) with similarities to atherosclerosis but also particular features of endothelial dysfunction associated to the alloimmune conflict and humoral responses toward the graft. Intravascular ultrasound (IVUS) is the validated invasive method for late CAV diagnosis, but occurs lesions are established. Identification of reliable non-invasive early endothelial injury biomarkers that reflect mechanisms of cardiac damage thus remain a major challenge to optimize therapeutic management of post transplant morbidity. Endothelial dysfunction is a central feature of both CAV and CAD and results from a desquilibrium in the balance of endothelial lesion and repair that is partly controlled by recipient immune system. Through their expression of receptors sensing antibodies (FcR CD16) and endothelial stress-induced signals (CX3CR1 fractalkine receptor and NKG2D MICA receptors), Natural Killer (NK) cells represent effector cells with unique potential to generate both humoral and innate immune injury of graft endothelium.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
HTC:heart transplanted recipients
blood samples
blood samples
blood samples

Primary Outcomes

Analysis of endothelial lesion-repair biomarkers
time frame: 24 MONTHS

Secondary Outcomes

Analysis of anti endothelial NK innate immune responses parameters
time frame: 24 MONTTHS

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subject > 18 years at the time of the inclusion, - Subject having benefited from a heart transplant more than 11 months ago in the service of cardiac surgery concerned whatever is the treatment to immunosuppresseur current - Subject benefiting from a coronarography within the framework of their surveillance comment-Clerk's Office beyond 12 months - Subject having given their consent - Affiliated to the Social Security * HTC with Cardiac allograft vasculopathy: - Subject with coronaropathies diagnosed by the coronarography * TC without Cardiac allograft vasculopathy: - Subject without coronaropathies diagnosed by the coronarography * untransplanted - Untreated Subject by immunosuppresseurs - Subject without antécédaent of transfusion - Subject without history of transplantations - Subject with coronaropathies diagnosed by a coronarography Exclusion Criteria: - Presenting a contraindication to the coronarography - Subject refusing to practise the examination of coronarography - Subject reaches(affects) of a cancer other one than cutaneous - Subject achieves of hepatic Incapacity (ALAT and\or ASAT > 3N)

Additional Information

Official title Identification of Non Invasive Biomarkers of Immune Endothelial Injury and Repair Associated With Cardiac Allograft Vasculopathy
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Assistance Publique Hopitaux De Marseille.