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ChanGes In Right ventricular volumes And Function Following diurEtic Treatment In Pulmonary arterial hypertension patients with decompensated right heart failure (GIRAFFE)

The primary objective of the study is to evaluate the effect of diuretics on right ventricular function and volume properties in patients with symptomatic right heart failure and PH.

Biomarker activity in adult patients with pulmonary hypertension.

The aim of this project is to evaluate the clinical value of biomarkers in adult patients with pulmonary hypertension, in particular:1) To quantify biomarkers of neurohormonal activity as NTproBNP, endotheline-1 and of immunological activity as CRP…

The effects of treatment on the right ventricular exertional contractile reserve in chronic tromboembolic pulmonary hypertension patients

The aim of this study is to evaluate the effects of treatment on the exertional contractile reserve and RV-arterial coupling during exercise in CTEPH patients. Furthermore, we evaluate the effects on the exertional contractile reserve and RV-…

A prospective, multicenter, single-arm, open-label, phase 4 study to evaluate the effects of macitentan on Right vEntricular remodeling in Pulmonary ArterIal hypeRtension assessed by cardiac magnetic resonance imaging

The primary objective of the study is to evaluate the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic PAH.Secondary objectivesTo evaluate the safety and tolerability of macitentan in patients with…

Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography.

To evaluate image quality and accuracy of detection of perfusion defects associated with pulmonary pathology on iodine maps of the lung that are created by two different CT techniques: 1. A standard of care CTPA with DECT and 2. A new technique that…

A Multicenter, Single-arm, Open-label, Phase 3b Study to Assess the Effects of Switching From Flolan® to ACT-385781A in Patients with Pulmonary Arterial Hypertension

- To evaluate the change in cardiac hemodynamics from baseline to 3-month following switch from Flolan to EFI in patients with PAH.- To evaluate the safety and tolerability of switching from Flolan to EFI in patients with PAH.- To evaluate the…

Dyspnoea in Pulmonary Arterial Hypertension: Targeting the Diaphragm muscle

PRIMARY OBJECTIVE:To determine the contractile strength and the (ultra)structure of single diaphragm muscle fibers of CTEPH patients SECONDARY OBJECTIVES:1. To determine whether diaphragm muscle fiber weakness is part of a generalized muscle…

A prospective, multicenter, open-label extension of FUTURE 3 to assess the safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension

To evaluate the long-term safety, tolerability and efficacy of the pediatric formulation of bosentan two versus three times a day in children with pulmonary arterial hypertension (PAH).

Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with symptomatic Pulmonary Arterial Hypertension (PAH).

BAY 63 2521 is a stimulator of the soluble guanylate cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially pulmonary hypertension (PH).To assess the long-term safety and tolerability of BAY 63 2521 in the treatment…

A Single-arm Open Label Study Evaluating the Impact on Lifestyle of a New Thermo-stable Formulation of Flolan in Subjects with Pulmonary Arterial Hypertension (PAH) (FLR115332)

Primary:* To describe the effect of the new thermo stable formulation of FLOLAN on quality of life in patients switching from the currently marketed FLOLAN to the new thermo stable formulation.* To determine the dose titration requirementSecondary…

Long-term extension, multi-centre, multi-national study to evaluate the safety and tolerability of oral BAY 63-2521 (1 mg, 1.5 mg, 2 mg, or 2.5 mg tid) in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH).

BAY 63 2521 is a stimulator of the soluble guanylate cyclase (sGC) and is intended for the treatment of cardiovascular diseases, especially pulmonary hypertension (PH).To assess the longterm safety and tolerability of oral BAY 63-2521 in patients…

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).

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.

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…

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).

Intravenous Administration of In Vitro Expanded Mesenchymal Stem Cells in Patients with Pulmonary Arterial Hypertension due to Systemic Sclerosis;
A Safety and Feasibility Study

The main objective is assessment of safety and feasibility of intravenous administration of autologous, in vitro expanded, mesenchymal stem cells in patients with pulmonary arterial hypertension due to systemic sclerosis. The secondary objective is…

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…

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…

An extension study to QTI571A2301 to evaluate the longterm safety, tolerability and efficacy of oral QTI571 (imatinib) in the treatment of severe pulmonary arterial hypertension.

Primary: To evaluate the long-term safety and tolerability of QTI571.Secondary: * Continue to evaluate the long-term efficacy of QTI571 as measured by the change in6MWD from baseline.* Continue to assess time to clinical worsening (TTCW) endpoints…

An open-label, long term extension study for treatment of pulmonary arterial hypertension in paediatric patients aged 8 years up to 18 years who have participated in AMB112529 and in whom continued treatment with ambrisentan is desired (AMB114588)

Primary: Longterm safety and tolerability of 2 dosages of ambrisentan. Secundary: Supportive efficacy data.