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Pulmonary hypertension in sarcoidosis: optimizing the diagnostic approach

The first objective of the study is to predict the prevalence of PH in sarcoidosis with pulmonary involvement, and to optimize the diagnostic approach in screening for PH associated sarcoidosis using the RHC as gold standard (Galie, 2009). The…

Long-term single-arm open-label phase 3 study, to assess the safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension

To assess the long-term safety and tolerability of selexipag (ACT-293987) in patients with pulmonary arterial hypertension (PAH).

Towards a better understanding of patients in the *TWILIGHT zone* of Pulmonary Hypertension (OPTIEK2)

The main objective of the current study is to evaluate which patients in the twilight zone of PH will benefit from PAH specific therapy. We will assess the (early) response to PAH specific treatment and determine potential predictors of adverse…

Quantification of pulmonary vascular remodelling in pulmonary arterial hypertension patients using positron emission tomography

To non-invasively quantify pulmonary vascular remodeling in pulmonary arterial hypertension using [18F]-FLT (determination hyperproliferation).

Right Ventricular neurohormonal signalling in patients with Pulmonary Arterial Hypertension using Positron Emission Tomography

Therefore, the aim of our study is to determine whether and when changes in sympathetic signalling in the RV of IPAH patients occur, using [11C]-HED and [11C]-CGP-12177 PET imaging.

Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Safety objective:• To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects withinoperable CTEPH.Efficacy objectives:• To evaluate the long term effects of macitentan 10 mg on exercise capacity andfunctional class (FC).

*Cost-effectiveness of tailoring anticoagulant therapy by a VTE recurrence prediction model in patients with venous thrombo-embolism as compared to care-as-usual: the VISTA study.*

OBJECTIVESThe objective is to quantify the cost-effectiveness and efficacy of formally applying the guideline evaluating the risk-benefit ratio of the duration of anticoagulant therapy (VKA treatment) by a previously developed VTE recurrence…

Combined Pressure and Doppler Flow Velocity Assessment In Pulmonary Hypertension

In this explorative study, we aim to investigate whether MVR obtained with Doppler flow velocity, is a better predictor of adverse outcome than PVR obtained with Swan-Ganz measurements.

Heparin management and hemostatic risk evaluation in patients undergoing pulmonary thrombo-endarterectomy

To provide evidence demonstrating that ACT-guided heparin management during pulmonary thrombo-endarterectomy (PTE) involving cardiopulmonary bypass (CPB) and deep hypothermic circulatory arrest (DHCA) will result in inadequate heparinization and…

Long-term outcome after heparin plus edoxaban versus heparin plus vitamin K antagonists for acute deep vein thrombosis and pulmonary embolism

To assess the long-term PE-related Quality of Life and to assess the cumulative incidence of PTS in patients with acute DVT, treated with heparin plus edoxaban in comparison to patients treated with heparin plus warfarin. Furthermore, the…

Resmon Pro Diary Pilot Study - Evaluation of Vivisol Service to remotely prevent COPD exacerbations

This pilot does not aim to demonstrate the effectiveness of the system. The effectiveness of the system has been demonstrated in the recently published study: Chromed study, a multi-center Randomized Controlled Study.This pilot aims to obtain…

A Study Evaluating the Long-term Efficacy and Safety of Ralinepag in Subjects with PAH via an Open-label Extension (ADVANCE Extension)

This study has been transitioned to CTIS with ID 2023-509305-68-00 check the CTIS register for the current data. To evaluate the long-term safety and tolerability of ralinepag (ADP811) in subjects who participated in a preceding Phase 2 or Phase 3…

Prevalence of asymptomatic deep vein thrombosis in COVID-19 patients admitted to the ward

To establish a point prevalence of asymptomatic proximal lower extremity DVT in patients admitted to the ward with COVID-19.

A multiple dosing study to demonstrate the safety, tolerability, pharmacokinetics and efficacy potential of intravenously administered ANXV (a recombinant human Annexin A5) in patients with confirmed moderate to severe COVID-19; The CO-ANNEXIN Study.

Primary Objective:To evaluate the efficacy potential, safety and tolerability of intravenously administered ANXV, in ascending doses, and two different dosing regimens, in patients with confirmed moderate to severe COVID-19.Secondary Objectives:To…

Safety and Efficacy of Low Molecular Weight Heparin for 72 Hours Followed by Dabigatran for the Treatment of Acute Intermediate-Risk Pulmonary Embolism

The primary objective is to determine whether treatment of acute intermediate-risk PE (as defined by the inclusion and exclusion criteria) with parenteral anticoagulation for at least 72 hours after diagnosis, followed by dabigatran over 6 months,…

Non-invasive assessment of lung remodelling in patients with pulmonary arterial hypertension (PAH) using [18F]-FLT PET imaging.

To investigate whether increased vascular cell proliferation in the lung of PAH patients can be assessed using [18F]-FLT-PET/CT imaging.

Experimental in vitro characterization of chronic thromboembolic pulmonary hypertension.

The primary objective of this study is to investigate the role of vascular cells, with focus on pulmonary arterial endothelial cells (PAEC), in the development and pathogenesis of extensive thromboembolisms as observed in CTEPH.

A phase III open-label extension study to evaluate long-term safety and efficacy of PRM-151 in patients with Idiopathic Pulmonary Fibrosis (IPF)

Study WA42294 is a Phase III open-label extension (OLE) study to assess the long-term safety, efficacy, and pharmacokinetics of PRM-151 in patients with IPF with or without concurrent treatment with pirfenidone or nintedanib. Patients with IPF who…

The TRISTARDS trial - ThRombolysIS Therapy for ARDS
A Phase IIb/III operationally seamless, open-label, randomised, sequential, parallel-group adaptive study to evaluate the efficacy and safety of daily intravenous alteplase treatment given up to 5 days on top of standard of care (SOC) compared with SOC alone, in patients with acute respiratory distress syndrome (ARDS) triggered by COVID-19.

Main objective is to evaluate the efficacy and safety of two (Part 1) different dosing regimen and of one dosing regimen (Part 2) of intravenous alteplase given for up to 5 days on top of standard of care (SOC) compared with SOC alone in ARDS…

changed right heart volumes and function following diuretic withdrawal in pulmonary hypertension

To evaluate the effect of diuretics on volumes and function of the right heart in pulmonary hypertension patients.