Iloprost for Bridging to Heart Transplantation in PH
Status:
Withdrawn
Trial end date:
2015-03-17
Target enrollment:
Participant gender:
Summary
Trial Rationale/ Justification To assess efficacy and safety of inhaled Iloprost in treatment
naïve patients with left heart failure and pulmonary hypertension, who are on the waiting
list for orthotopic heart transplantation. As patients often show increasing hemodynamic
values while waiting for a donor organ, the transplantation becomes infeasible at the time of
identification of an appropriate donor organ when reaching the exclusion limits. Therefore,
there is a high need of improvement and stabilisation of the patients' hemodynamic values as
PVR, PAP and TPG. In a retrospective, non-controlled study inhaled Iloprost has already shown
a beneficial effect on the hemodynamics as reduction of PVR, TPG and CI (Schulz 2010).
Treatment with inhaled Iloprost could stabilize the hemodynamics and prevent the patients
from being classified as ineligible by the time an appropriate donor organ is identified.
However, the adverse event profile regarding frequency, time-dependency has to be further
validated to show safety and tolerability of inhaled Iloprost in this indication.
All patients can be transferred to a long-term medically supervised observation period with
inhaled Iloprost therapy.