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Short term effects of exercise training on exercise capacity and quality of life in patients with pulmonary arterial hypertension: protocol for a randomised controlled trial

Background: Advances in the understanding and management of pulmonary arterial hypertension have enabled earlier diagnosis and improved prognosis. However, despite best available therapy, symptoms of exertional dyspnoea and fatigue are commonly reported and result in a reduced capacity to perform daily activities and impaired quality of life. Exercise training has demonstrated efficacy in individuals with other respiratory and cardiovascular diseases. Historically, however, exercise training has not been utilised as a form of therapy in pulmonary arterial hypertension due to the perceived risk of sudden cardiac death and the theoretical possibility that exercise would lead to worsening pulmonary vascular haemodynamics and deterioration in right heart function. Now, with the advances in pharmaceutical management, determining the safety and benefits of exercise training in this population has become more relevant. Only three studies of supervised exercise training in pulmonary arterial hypertension have been published. These studies demonstrated improvements in exercise capacity and quality of life, in the absence of adverse events or clinical deterioration. However, these studies have not utilised an outpatient-based, whole body exercise training program, the most common format for exercise programs within Australia. It is uncertain whether this form of training is beneficial and capable of producing sustained benefits in exercise capacity and quality of life in this population.Design/Methods: This randomised controlled trial will determine whether a 12 week, outpatient-based, supervised, whole body exercise training program, followed by a home-based exercise program, is safe and improves exercise capacity and quality of life in individuals with pulmonary arterial hypertension. This study aims to recruit 34 subjects who will be randomly allocated to the exercise group (supervised exercise training 3 times a week for 12 weeks, followed by 3 sessions per week of home exercise for 12 weeks) or the control group (usual medical care). Subjects will be assessed at baseline, 12 weeks and 24 weeks.DiscussionThis study will determine whether outpatient-based, whole body exercise training is beneficial and safe in individuals with pulmonary arterial hypertension. Additionally, this study will contribute to clinical practice guidelines for this patient population.Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12609000502235)

Multi tyrosine kinase inhibitor dasatinib as novel cause of severe pre-capillary pulmonary hypertension?

Background: Pulmonary hypertension (PH) is a life-threatening disease with poor prognosis. Encouraging efforts have been made to target the main vasoproliferative aspects of the disease. Promising emerging therapeutics are tyrosine kinase inhibitors such as imatinib.Case presentationHere, we discuss the relevance of previously published cases and add another well-characterised patient who developed pre-capillary PH under long-term therapy with the multi-tyrosine kinase inhibitor dasatinib approved for therapy of chronic myeloic leukemia (CML) and Philadelphia chromosome positive acute lymphocytic leukaemia (mean time of all patients on dasatinib: 26 months). Hence, we discuss the possibility of dasatinib itself causing PH after long-term therapy and turn specialist's attention to this possible severe side effect.At present, the true incidence of dasatinib-associated PH remains illusive and systematic data regarding haemodynamics are missing. Conclusion: We therefore recommend systematic screening of dasatinib-treated patients for pulmonary hypertension and subsequent collection of haemodynamic data.

Cardiac safety of indacaterol in healthy subjects: a randomized, multidose, placebo- and positive-controlled, parallel-group thorough QT study

Background: Indacaterol is a novel once-daily ultra long-acting beta2-agonist for the treatment of chronic obstructive pulmonary disease. It is known that beta2-agonists, like other adrenergic compounds, can prolong the QT-interval. This thorough QT/QTc study (as per ICH E14 guideline) evaluated the effect of indacaterol on the QT interval in healthy subjects. Methods: In this randomized, double-blind, parallel-group, placebo- and positive-controlled (open-label moxifloxacin) study, non-smoking healthy subjects (18-55 years, body mass index: 18.5-32.0 kg/m2) were randomized (4:4:2:4:1) to 14-day treatment with once-daily indacaterol (150 mcg, 300 mcg, or 600 mcg), placebo, or placebo/moxifloxacin (double-blind 14-day treatment with placebo and a single open-label dose of 400 mg moxifloxacin on Day 14). The primary endpoint was the change from baseline on Day 14 in QTcF (QT interval corrected for heart rate using Fridericia's formula). Results: In total, 404 subjects were randomized to receive indacaterol (150 [n=108], 300 [n=108], 600 mcg [n=54]), placebo (n=107), or placebo/moxifloxacin (n=27); 388 subjects completed the study. Maximal time-matched mean (90% confidence intervals) treatment differences from placebo in QTcF change from baseline on Day 14 were 2.66 (0.55, 4.77), 2.98 (1.02, 4.93) and 3.34 (0.86, 5.82) ms for indacaterol 150 mcg, 300 mcg and 600 mcg, respectively. Study sensitivity was confirmed with moxifloxacin demonstrating a significant maximal time-matched QTcF prolongation of 13.90 (10.58, 17.22) ms compared to placebo. All indacaterol doses were well tolerated. Conclusion: Indacaterol, at doses up to 600 mcg once daily (2-4 times the therapeutic dose) does not have any clinically relevant effect on the QT interval.ClinicalTrials.gov NCT01263808

Bedside percutaneous tracheostomy: a prospective randomised comparison of PercuTwist versus Griggs' forceps dilational tracheostomy.

Bedside percutaneous tracheostomy: a prospective randomised comparison of PercuTwist versus Griggs' forceps dilational tracheostomy.

Anaesth Intensive Care. 2011 Mar;39(2):209-16

Authors: Montcriol A, Bordes J, Asencio Y, Prunet B, Lacroix G, Meaudre E

Tracheostomy is considered the airway management of choice for patients who require prolonged mechanical ventilation. The development of percutaneous techniques offers many advantages including the ability to perform the procedure in the intensive care unit. The aim of this study was to compare the controlled rotating dilation method (PercuTwist) and the Griggs' forceps dilational tracheostomy. Patients over 18 years of age undergoing tracheostomy in the intensive care unit were included in the study. They were divided in two random samples--either PercuTwist or forceps dilational tracheostomy. Data collected prospectively included demographic characteristics, procedure duration, blood gas analysis, intracranial pressure, arterial blood pressure and heart rate before and after the procedure. Any complications during or after the procedure due to the tracheostomy were also recorded. Contrary to the main hypothesis, PercuTwist technique took significantly longer to perform than forceps dilational tracheostomy technique (five minutes [2 to 25] vs three minutes [1 to 17][P=0.006]). A significant increase in P(a)CO2 and decrease in arterial pH were observed in both groups between the pre-tracheostomy and post-tracheostomy blood gas analysis. Haemodynamic tolerance was good. Our results show that intracranial pressure is affected by the procedure whatever the technique used. However we did not observe a decrease in cerebral perfusion pressure. The incidence of complications was 23% (20/87). These complications were minor in 18/20 and were not significantly different between the two groups. In conclusion, we consider that the PercuTwist technique is safe despite the longer duration of the procedure. Nevertheless the forceps dilational technique remains our routine procedure.

PMID: 21485668 [PubMed - indexed for MEDLINE]

Recurrent hemoptysis: an emerging life-threatening complication in idiopathic pulmonary arterial hypertension.

Recurrent hemoptysis: an emerging life-threatening complication in idiopathic pulmonary arterial hypertension.

Chest. 2011 Mar;139(3):690-3

Authors: Zyłkowska J, Kurzyna M, Pietura R, Fijałkowska A, Florczyk M, Czajka C, Torbicki A

Hemoptysis is a rarely reported complication of idiopathic pulmonary arterial hypertension (IPAH). We present the case of a 27-year-old woman with IPAH, who suffered from recurrent hemoptysis and who was treated with sitaxsentan and treprostinil and remained stable in World Health Organization functional class II. During several episodes of active hemoptysis, the patient underwent bronchial artery embolization (BAE), always with good immediate results. She developed severe respiratory insufficiency and died of electromechanical dissociation 2 days after another episode, despite effective bleeding control. Recurrent hemoptysis in patients with IPAH emerges as a potential indication for urgent placement on the lung transplant list, independent from the classic prognostic factors of functional class and indices of right-sided ventricular function. Repeated BAE should not be considered as a definitive treatment in patients with pulmonary arterial hypertension with recurrent bleeding, although it may help in bridging patients to lung transplant.

PMID: 21362657 [PubMed - indexed for MEDLINE]

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