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Iloprost for Bridging to Heart Transplantation in PH

NCT02482402 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2019-12-23

No results posted yet for this study

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.

Conditions

  • Chronic Left Ventricular Failure
  • Pulmonary Hypertension

Interventions

DRUG

Inhaled Iloprost

Treatment effect will be controlled at each study visit and the dose and/or inhalation frequency will be adapted.

DRUG

Placebo

inhalation solution placebo

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Heidelberg University

    lead OTHER

Principal Investigators

  • Ekkehard Grünig, MD · Thoraxclinic at the University Hospital Heidelberg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-03-17
Completion
2015-03-17

Countries

  • Germany

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02482402 on ClinicalTrials.gov