Standardised exercise training is feasible, safe and effective in pulmonary arterial and chronic thromboembolic pulmonary hypertension - results from a large European multicentre randomised controlled trial

2020 ◽  
Author(s):  
Ekkehard Grünig ◽  
Alison Mackenzie ◽  
Andrew J. Peackock ◽  
Christina Eichstaedt ◽  
Nicola Benjamin ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Randomised Controlled Trial ◽  
Exercise Training ◽  
Controlled Trial ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Thromboembolic Pulmonary Hypertension ◽  
Pulmonary Arterial ◽  
Randomised Controlled

scholarly journals Multicentre randomised controlled trial of balloon pulmonary angioplasty and riociguat in patients with chronic thromboembolic pulmonary hypertension: protocol for the MR BPA study

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e028831 ◽  
Author(s):  
Takashi Kawakami ◽  
Hiromi Matsubara ◽  
Kohtaro Abe ◽  
Masaharu Kataoka ◽  
Shun Kohsaka ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Randomised Controlled Trial ◽  
Soluble Guanylate Cyclase ◽  
Pulmonary Arterial Pressure ◽  
Controlled Trial ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Balloon Pulmonary Angioplasty ◽  
Thromboembolic Pulmonary Hypertension ◽  
Pulmonary Arterial ◽  
Randomised Controlled

IntroductionManagement of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) remains a clinical challenge. Currently, medical treatment involving pulmonary vasodilators (such as soluble guanylate-cyclase stimulators) is recommended, primarily for ameliorating symptoms. More recently, balloon pulmonary angioplasty (BPA) has been developed as alternative treatment for inoperable CTEPH. This study aimed to compare the efficacy and safety of BPA and riociguat (a soluble guanylate-cyclase stimulator) as treatments for inoperable CTEPH.Methods and analysisThis study is a multicentre randomised controlled trial. Subjects with inoperable CTEPH were randomised (1:1) into either a BPA or riociguat group, and observed for 12 months after initiation of treatment. The primary endpoint will be the change in mean pulmonary arterial pressure from baseline to 12 months after initiation of treatment. For primary analysis, we will estimate the least square means difference and 95% CI for the change of pulmonary arterial pressure between the groups at 12 months using the analysis of covariance adjusted for allocation factors.Ethics and disseminationThis study and its protocols were approved by the institutional review board of Keio University School of Medicine and each participating institution. Written informed consent was obtained from all participants. Results will be disseminated at medical conferences and in journal publications.Trial registration numberUniversity Hospital Medical Information Network Clinical Trial Registry (UMIN000019549); Pre-results.

scholarly journals Standardized exercise training is feasible, safe, and effective in pulmonary arterial and chronic thromboembolic pulmonary hypertension: results from a large European multicentre randomized controlled trial

2020 ◽  
Author(s):  
Ekkehard Grünig ◽  
Alison MacKenzie ◽  
Andrew J Peacock ◽  
Christina A Eichstaedt ◽  
Nicola Benjamin ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Exercise Training ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Functional Class ◽  
European Countries ◽  
Walking Distance ◽  
Control Group ◽  
Randomized Controlled ◽  
Thromboembolic Pulmonary Hypertension ◽  
Pulmonary Arterial

Abstract Aims This prospective, randomized, controlled, multicentre study aimed to evaluate efficacy and safety of exercise training in patients with pulmonary arterial (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). Methods and results For the first time a specialized PAH/CTEPH rehabilitation programme was implemented in 11 centres across 10 European countries. Out of 129 enrolled patients, 116 patients (58 vs. 58 randomized into a training or usual care control group) on disease-targeted medication completed the study [85 female; mean age 53.6 ± 12.5 years; mean pulmonary arterial pressure 46.6 ± 15.1 mmHg; World Health Organization (WHO) functional class II 53%, III 46%; PAH n = 98; CTEPH n = 18]. Patients of the training group performed a standardized in-hospital rehabilitation with mean duration of 25 days [95% confidence interval (CI) 17–33 days], which was continued at home. The primary endpoint, change of 6-min walking distance, significantly improved by 34.1 ± 8.3 m in the training compared with the control group (95% CI, 18–51 m; P < 0.0001). Exercise training was feasible, safe, and well-tolerated. Secondary endpoints showed improvements in quality of life (short-form health survey 36 mental health 7.3 ± 2.5, P = 0.004), WHO-functional class (training vs. control: improvement 9:1, worsening 4:3; χ2  P = 0.027) and peak oxygen consumption (0.9 ± 0.5 mL/min/kg, P = 0.048) compared with the control group. Conclusion This is the first multicentre and so far the largest randomized, controlled study on feasibility, safety, and efficacy of exercise training as add-on to medical therapy in PAH and CTEPH. Within this study, a standardized specialized training programme with in-hospital start was successfully established in 10 European countries.

scholarly journals Study protocol for a randomised controlled trial of exercise training in pulmonary hypertension (ExTra_PH)

2018 ◽  
Vol 18 (1) ◽  
Author(s):  
Norman R. Morris ◽  
Menaka Louis ◽  
Wendy Strugnell ◽  
Julie Harris ◽  
Aaron Lin ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Randomised Controlled Trial ◽  
Exercise Training ◽  
Study Protocol ◽  
Controlled Trial ◽  
Randomised Controlled

scholarly journals Quality of life in patients with chronic thromboembolic pulmonary hypertension

2016 ◽  
Vol 48 (2) ◽  
pp. 526-537 ◽  
Author(s):  
Stephen C. Mathai ◽  
Hossein-Ardeschir Ghofrani ◽  
Eckhard Mayer ◽  
Joanna Pepke-Zaba ◽  
Sylvia Nikkho ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pulmonary Hypertension ◽  
Negative Impact ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Physical Capability ◽  
Measurement Tools ◽  
Thromboembolic Pulmonary Hypertension ◽  
Pulmonary Arterial ◽  
Randomised Controlled

Patients with chronic thromboembolic pulmonary hypertension (CTEPH) experience debilitating symptoms that have a negative impact on their quality of life (QoL) in terms of physical capability, psychological wellbeing and social relationships. The use of QoL measurement tools is important in the assessment of treatment efficacy and in guiding treatment decisions. However, despite the importance of QoL, particularly to the patient, it remains under-reported in clinical studies of CTEPH therapy. CTEPH is unique in pulmonary hypertension in that it is potentially curable by surgery; however, a proportion of patients either have residual PH following surgery or are not operable. Although some patients with CTEPH have been treated off-label with pulmonary arterial hypertension-specific therapies, there have been few randomised controlled trials of these therapies in patients with CTEPH. Moreover, in these trials QoL outcomes are variably assessed, and there is little consistency in the tools used. Here we review the assessment of QoL in patients with CTEPH and the tools that have been used. We also discuss the effect of surgical intervention and medical therapies on QoL. We conclude that further studies of QoL in patients with CTEPH are needed to further validate the optimal QoL tools.

Effect of Supervised Training Therapy on Pulmonary Arterial Compliance and Stroke Volume in Severe Pulmonary Arterial Hypertension and Inoperable or Persistent Chronic Thromboembolic Pulmonary Hypertension

Respiration ◽  
2021 ◽  
pp. 1-10
Author(s):  
Christian Nagel ◽  
Nicola Benjamin ◽  
Benjamin Egenlauf ◽  
Christina A. Eichstaedt ◽  
Christine Fischer ◽  
...  
Keyword(s):  
Pulmonary Hypertension ◽  
Pulmonary Arterial Hypertension ◽  
Exercise Training ◽  
Stroke Volume ◽  
Arterial Compliance ◽  
Chronic Thromboembolic Pulmonary Hypertension ◽  
Training Group ◽  
Control Group ◽  
Thromboembolic Pulmonary Hypertension ◽  
Pulmonary Arterial

<b><i>Background:</i></b> Pulmonary arterial compliance (PAC) is a prognostic parameter in pulmonary arterial hypertension (PAH) reflecting the elasticity of the pulmonary vessels. <b><i>Objectives:</i></b> The objective of this post hoc analysis of a prospective randomized controlled trial (RCT) was to assess the effect of exercise training on PAC and stroke volume (SV) in patients with PAH and persistent/inoperable chronic thromboembolic pulmonary hypertension (CTEPH). <b><i>Method:</i></b> From the previous RCT, 43 out of 87 patients with severe PAH (<i>n</i> = 29) and CTEPH (<i>n</i> = 14) had complete haemodynamic examinations at baseline and after 15 weeks by right heart catheterization and were analysed (53% female, 79% World Health Organization functional class III/IV, 58% combination therapy, 42% on supplemental oxygen therapy, training group <i>n</i> = 24, and control group <i>n</i> = 19). Medication remained unchanged for all patients. <b><i>Results:</i></b> Low-dose exercise training at 4–7 days/week significantly improved PAC (training group 0.33 ± 0.65 mL/mm Hg vs. control group −0.06 ± 1.10 mL/mm Hg; mean difference 0.39 mL/mm Hg, 95% confidence interval [CI] 0.15–0.94 mL/mm Hg; <i>p</i> = 0.004) and SV (training group 9.9 ± 13.4 mL/min vs. control group −4.2 ± 11.0 mL/min; mean difference 14.2 mL, 95% CI 6.5–21.8 mL; <i>p</i> &#x3c; 0.001) in the training versus control group. Furthermore, exercise training significantly improved cardiac output and pulmonary vascular resistance at rest, peak oxygen consumption, and oxygen pulse. <b><i>Conclusions:</i></b> Our findings suggest that supervised exercise training may improve right ventricular function and PAC at the same time. Further prospective studies are needed to evaluate these findings.

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