Why the study?
Does bosentan improve hemodynamic parameters in adult patients with pulmonary hypertension secondary to systolic heart failure?
Does bosentan improve hemodynamic parameters in adult patients with pulmonary hypertension secondary to systolic heart failure?
Bosentan may improve pulmonary hemodynamics in a subset of patients with pulmonary hypertension secondary to systolic heart failure, potentially bridging them to advanced therapies, though tolerability is a significant concern.
Hypothesis-generating for bosentan in PH secondary to systolic HF; prospective trials needed before clinical adoption.
OBJECTIVES: The dual endothelin receptor antagonist bosentan improves pulmonary vascular resistance (PVR) in patients with primary pulmonary hypertension (PH). The effects of bosentan on secondary PH due to systolic heart failure (HF) are not well defined. This study evaluates the effect and tolerability of bosentan in patients with PH secondary to HF. METHODS: Seventeen adult HF patients with PH and New York Heart Association class III-IV symptoms were treated with bosentan, 62.5 mg twice daily, for 1 month, which was gradually increased to 125 mg twice daily thereafter. Right heart catheterization (RHC), a clinical evaluation and echocardiographic measurements were performed at baseline and at 4 ± 3 (mean ± SD) months of follow-up. Response to bosentan was defined as an improvement in clinical, echocardiographic and RHC parameters. RESULTS: Six patients did not complete the study (therapy was discontinued due to hypotension, elevated liver enzymes or acute decompensation of HF), 11 patients completed the follow-up; 9 patients responded to therapy. Systemic arterial pressures, pulmonary pressures, PVR and the transpulmonary gradient significantly decreased compared with baseline levels in 9 responders (p = 0.05, 0.05, 0.01 and 0.004, respectively), and 4 became eligible for heart transplantation and 3 for left ventricular assist device implantation. CONCLUSIONS: Bosentan decreased pulmonary pressures and PVR in the majority of patients with PH secondary to systolic HF, thereby allowing them to be considered candidates for heart transplantation.
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Padeletti et al. (2013) studied this question.
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