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PubMed | Convent Hospital Elisabethinen, University Teaching Hospital Hall in Tyrol, Community Hospital Wels Grieskirchen, Innsbruck Medical University and University of Salzburg
Type: | Journal: Heart, lung & circulation | Year: 2016

In this multi-centre, randomised, placebo-controlled pilot trial, we investigated the clinical and haemodynamic effects of the endothelin-receptor blocker Bosentan in patients with heart failure, preserved ejection fraction and pulmonary hypertension (PH-HFpEF).Eligible patients received either 12 weeks of Bosentan therapy, or a placebo drug. Patients were thereafter followed for a further period of 12 weeks without the study medication. At three points during the study (study Commencement, Week 12 and Week 24), a six-minute walk test (6MWT), echocardiographic and laboratory assessments were performed, as well as a quality of life survey. Right heart catheterisation (RHC) was undertaken at commencement only. The study was aborted early, after an interim analysis favoured the placebo.Six-minute walk distance (6MWD) did not change in the Bosentan group (309.796.3m (Commencement), 317.0126.1m (Week 12), 307.084.4m (Week 24); p=0.86), but almost reached statistical significance in the placebo group from 328.879.6m, to 361.698.2m and 384.074.9m (Week 24); p=0.075. In the placebo group, estimated systolic pulmonary artery pressure (measured via echocardiography) significantly decreased (from 62.316.7mmHg [Commencement], 45.313.9mmHg [Week 12], to 44.614.5mmHg [Week 24]; p=0.014) as did right atrial pressure (13.15.3 [Commencement], 10.03.8 [Week 12], to 9.43.2 [Week 24]; p=0.046).Despite this studys limited sample size and premature cessation, it nevertheless suggests that endothelin receptor blockade in patients with PH-HFpEF may have no beneficial effects and could even be detrimental in comparison to a placebo.

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