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1 November 2018

Combination therapy for Pulmonary hypertension using RacEcadotril

Patients with pulmonary hypertension often develop heart failure which is caused by narrowing of the blood vessels in the lungs. We wish to investigate whether a combination of two existing licensed drugs might improve the treatment for this new indication.

Step 1 is a randomised placebo controlled dose finding trial in 12 patients of a single dose of the drug racecadotril to see whether it can relax the blood vessels in the lung and increase blood flow. All patients will continue on a stable dose of the drug sildenafil or tadalafil. We will use plasma atrial natriuretic peptide (ANP) as a biomarker of the vasodilation properties of the therapy. Our primary aim is to determine the effect of racecadotril on plasma ANP concentration. The effect of racecadotril on the safety of the patient, further blood biomarkers and blood pressure measurements is also assessed.

Step 2 is a randomised placebo controlled trial of 12-14 days of repeated dosing in 12 patients, using the dose of racecadotril selected in step 1. All patients will be on a stable dose of the drug sildenafil or tadalafil. We want to know, primarily, whether any beneficial effects of the drug combination on ANP are maintained over a longer period without unacceptable side effects. The effect of racecadotril on further blood biomarkers, walking distances, and blood pressure measurements is also assessed.  

Trial status: Recruitment has ended and the results are being analysed.

Funder: British Heart Foundation and UCLH/UCL NIHR Biomedical Research Centre

Sponsor: University College London

ISRCTN: ISRCTN96717546

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