Trial intelligence / Profile preview

BRIDGE: Iloprost for PH in Left Heart Failure

NCT02482402Phase 2

Key facts

Status: Withdrawn
Start: Feb 2015
Primary completion: Mar 2015
Countries: 1
Sponsor: Heidelberg University
Modality: Orthosteric Ligands

Drugs: iloprost
Conditions: pulmonary hypertension (PH)

Overview

Phase 2, randomised, double-blind trial in pulmonary hypertension (PH) comparing Inhaled Iloprost with Placebo inhaled (2 arms). Primary endpoint: Safety and Tolerability at 12 weeks. Planned start Feb 2015; status: withdrawn.

Design

2 arms

Study design: RandomizedDouble-blind

Inhaled Iloprost
2.5-5 mcg inhaled 6 times daily
Placebo inhaled
Inhaled placebo solution

Who it enrols

Adult patients with left heart insufficiency and secondary pulmonary hypertension (mPAP >= 25 mmHg, PVR > 230 dyn x s x cm-5, TPG > 15 mmHg) on maximal conventional therapy, excluding those with other causes of PH or severe lung disease.

Endpoints

Primary

Safety and Tolerability12 weeks

Secondary

Right Atrial Pressure12 weeks
Mean Pulmonary Arterial Pressure12 weeks
Pulmonary Arterial Wedge Pressure12 weeks
Cardiac Output12 weeks
Cardiac Index12 weeks
Venous Oxygen Saturation12 weeks
Systolic Pulmonary Arterial Pressure12 weeks
Tei Index12 weeks

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