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Trial completion date, Trial primary completion date: MoD: Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension (clinicaltrials.gov) - Jul 13, 2020 P3, N=100, Not yet recruiting, 2) Vasodilators have greater effect on TLC and TLCO than Immunosupressor (0.048 vs -0.034 for TLC, -0.06 vs -0.17 for TLCO); while Immunosupressor's averaged effect was better on Spirometry outcome (0.07 vs -0.01 for FVC ) Conclusion : The debiasing machine learning framework is a promising method for the optimisation of personalized therapies in chronic lung diseases. Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2026
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Enrollment closed, Trial completion date, Trial primary completion date: End-Stress: Endothelin Receptor Function and Acute Stress (clinicaltrials.gov) - Jul 9, 2020 P=N/A, N=320, Active, not recruiting, Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2026 Recruiting --> Active, not recruiting | Trial completion date: Apr 2020 --> Sep 2020 | Trial primary completion date: Apr 2020 --> Sep 2020
- |||||||||| [VIRTUAL] Delayed Diagnosis of Alveolar Capillary Dysplasia with Misalignment of the Pulmonary Vein in a Term Infant (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_5735;
She was started on sildenafil, treprostinil, diuretics, and a five-day course of methylprednisolone (2 mg/kg/day)...During her third admission at sixteen months of age, she was intubated for acute respiratory failure and had refractory pulmonary hypertension despite iNO, iloprost, treprostinil, bosentan, and sildenafil...Broad phenotypic differences have been reported for other FOXF1 mutations. Given her mild presentation and relatively prolonged survival, this variant may be characterized by a less severe presentation but no less fatal outcome.
- |||||||||| [VIRTUAL] Using Cardiopulmonary Exercise Testing to Evaluate the Effects of Target Medicine for Pulmonary Artery Hypertension (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_3427;
6MWD was significantly related to peak VO 2 , peak VO 2 /kg, VE/VCO 2 slope, peak HR, peak systolic pressure (r =0.641, P =0.002; r =0.562, P =0.008; r =-0.600, P =0.011; r =0.451, P =0.040; r =0.499, P =0.021). CONCLUSION : CPET can objectively and quantitatively evaluate the effects of target medicine for pulmonary artery hypertension, and correlate with the traditional index.
- |||||||||| sildenafil / Generic mfg., Tracleer (bosentan) / J&J, Roche, tadalafil / Generic mfg.
[VIRTUAL] Novel Intronic TBX4 Mutation Associated with Lung Disease, Pulmonary Arterial Hypertension and Skeletal Abnormalities with Variable Penetrance in a Single Family (ATS 2020 Virtual) - Jul 6, 2020 - Abstract #ATSI2020ATS-I_3337; He was treated with inhaled nitric-oxide and later transitioned to sildenafil...Over the subsequent 2 years, his lung disease progressed; most recent follow-up (at age 5) was notable for a 4L oxygen requirement and moderate-severe pulmonary arterial hypertension requiring tadalafil and bosentan...Neither the patient's mother nor older sister carried the TBX4 variant; both were healthy and did not have skeletal or respiratory findings. Our study characterizes a novel intronic variant in TBX4 associated with pulmonary hypertension, a lung development disorder, and limb abnormalities in a single family with variable penetrance.
- |||||||||| Opsumit (macitentan) / Nippon Shinyaku, J&J, Tracleer (bosentan) / J&J, Roche
Journal: Bosentan or Macitentan Therapy in Chronic Thromboembolic Pulmonary Hypertension? (Pubmed Central) - Jul 4, 2020 Our study characterizes a novel intronic variant in TBX4 associated with pulmonary hypertension, a lung development disorder, and limb abnormalities in a single family with variable penetrance. CTEPH patients receiving bosentan or macitentan have improved clinical outcomes till 2-year follow-up, without significant differences in outcomes between both therapies.
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Journal: From an innocent heart murmur to pulmonary arterial hypertension. (Pubmed Central) - Jun 9, 2020 Currently, pulmonary arterial hypertension persists, for which Bosentan (Actelion, USA) has been implemented as a long-term treatment...Therefore, it has become an essential diagnostic tool to reduce morbidity and mortality. Although the surgical correction of congenital heart disease with pulmonary arterial hypertension is feasible in some patients, its subsequent management is complex and has an adverse impact on the quality of life.
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[VIRTUAL] THE IMMUNOMODULATORY AND ANTI-INFLAMMATORY EFFECTS OF BOSENTAN IN SYSTEMIC SCLEROSIS () - May 22, 2020 - Abstract #EULAR2020EULAR_1963; The observed difference response to therapy between the two cohorts of patients was attributed to influence of ET-1 levels on the relative expression of ET-1 receptors on immune cells surface. Interestingly Bosentan, beside the already-known effect on promoting antigen presenting cells apoptosis, seem to exert its immunomodulatory activity also by deregulating functions that mainly involves the T cells and by promoting their apoptosis, which in turn reflect also its anti-inflammatory proprieties.
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Trial suspension: BOSRET: Safety of Bosentan in Type II Diabetic Patients (clinicaltrials.gov) - May 21, 2020 P1, N=22, Suspended, Interestingly Bosentan, beside the already-known effect on promoting antigen presenting cells apoptosis, seem to exert its immunomodulatory activity also by deregulating functions that mainly involves the T cells and by promoting their apoptosis, which in turn reflect also its anti-inflammatory proprieties. Recruiting --> Suspended
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Preclinical, Journal: The effects of bosentan on hyperoxia-induced lung injury in neonatal rats. (Pubmed Central) - May 7, 2020 Nonetheless, PAH pharmacotherapy should generally be avoided for most patients with PH-LHD. This experimental study showed that bosentan had a protective effect on hyperoxic lung injury through its anti-inflammatory properties.
- |||||||||| Clinical, Journal, HEOR: Medication adherence, hospitalization, and healthcare resource utilization and costs in patients with pulmonary arterial hypertension treated with endothelin receptor antagonists or phosphodiesterase type-5 inhibitors. (Pubmed Central) - Apr 11, 2020
Rates and numbers of rehospitalizations within 30 days post-discharge were similar between groups. Mean total costs were higher with endothelin receptor antagonists than phosphodiesterase type-5 inhibitors in all patients ($91,328 versus $72,401, P = 0.0003) and in adherent patients ($88,867 versus $56,300, P < 0.0001), driven by higher drug costs.
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Trial completion date, Trial initiation date, Trial primary completion date: MoD: Mono vs. Dual Therapy for Pediatric Pulmonary Arterial Hypertension (clinicaltrials.gov) - Apr 9, 2020 P3, N=100, Not yet recruiting, Mean total costs were higher with endothelin receptor antagonists than phosphodiesterase type-5 inhibitors in all patients ($91,328 versus $72,401, P = 0.0003) and in adherent patients ($88,867 versus $56,300, P < 0.0001), driven by higher drug costs. Trial completion date: Dec 2024 --> Dec 2025 | Initiation date: Apr 2020 --> Jul 2021 | Trial primary completion date: Dec 2024 --> Dec 2025
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Trial termination, FDG PET: Bosentan in Myocardium Metabolism and Perfusion Measured by 18F-FDG and 82Rb PET/CT on PAH and CTEPH (clinicaltrials.gov) - Mar 23, 2020 P=N/A, N=2, Terminated, Altogether, the results suggest that zinc deficiency up-regulates ET-1 signaling through HIF-1 activation and stimulates endothelial cell migration suggesting an important role of zinc in the vascular consequences of IH and OSA mediated by the HIF-1-ET- signaling. Completed --> Terminated; Slow patient recruitment after arrival of macitentan on the market
- |||||||||| Review, Journal: Endothelin Receptor Antagonists: Status Quo and Future Perspectives for Targeted Therapy. (Pubmed Central) - Mar 23, 2020
Treatment with approved endothelin receptor antagonists (ERAs), such as bosentan, ambrisentan, or macitentan, slow down PAH progression and relieves symptoms...Furthermore, in the SONAR (Study Of Diabetic Nephropathy With Atrasentan) trial, the selective ERA atrasentan reduced the risk of renal events in patients with diabetes and chronic kidney disease...Preclinical studies regarding heart failure, cancer, and fibrotic diseases have demonstrated promising effects, but clinical trials have not yet produced measurable results. Nevertheless, the potential benefits of ERAs may not be fully realized.
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Enrollment open: BOSRET: Safety of Bosentan in Type II Diabetic Patients (clinicaltrials.gov) - Mar 17, 2020 P1, N=22, Recruiting, Nevertheless, the potential benefits of ERAs may not be fully realized. Not yet recruiting --> Recruiting
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