NCT02482402: BRIDGE

Iloprost for Bridging to Heart Transplantation in Patients With Pulmonary Hypertension and Left Heart Failure A Randomized, Controlled, Double-blind, Parallel Group, Proof-of-concept Trial

Withdrawn Phase 2 Last updated 19 December 2019

What this trial tests

Phase 2 trial testing Inhaled Iloprost in Chronic Left Ventricular Failure. Withdrawn.

Timeline

1 February 2015

Primary endpoint
17 March 2015

17 March 2015

Quick facts

Lead sponsor	Heidelberg University
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Start date	1 February 2015
Primary completion	17 March 2015
Estimated completion	17 March 2015
Sites	2 locations across Germany

Drugs / interventions tested

• Inhaled Iloprost — full drug profile →
• Placebo

Conditions studied

• Chronic Left Ventricular Failure — all drugs for Chronic Left Ventricular Failure →
• Pulmonary Hypertension — all drugs for Pulmonary Hypertension →

Sponsor

Heidelberg University

Who can join

18 and older, any sex, with Chronic Left Ventricular Failure or Pulmonary Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• safety and tolerability measured by adverse events rates
  Time frame: baseline until end of study after 12 weeks
  The primary objective of the clinical trial is to acquire first data on safety and tolerability of inhaled Ilorpost in patients with left heart failure on the waiting list for orthotopic heart transplantation.. This proof-of-concept trial aims to evaluate the safety profile of inhaled Iloprost in this indication.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Prostacyclin for pulmonary arterial hypertension.
   Barnes H, Yeoh HL, Fothergill T, Burns A, et al · · 2019 · cited 42× · PMID 31042010 · DOI 10.1002/14651858.cd012785.pub2