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Pulmonary Arterial Hypertension clinical trials

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NCT ID: NCT02889315 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

LenusPro Pump in PAH Treated With Treprostinil

Start date: November 2013
Phase:
Study type: Observational

Subcutaneous treprostinil is used to treat pulmonary arterial hypertension (PAH). Due to local pain it causes a deterioration of quality of life or even abandonment of treatment. The aim of this study was to evaluate the safety and quality of life (QoL) in patients treated with treprostinil administration using an implantable Lenus Pro® pump. This is a observational study involving patients with PAH treated with a subcutaneous infusion of treprostinil with intolerable pain at the infusion site, who were therefore referred for pump implantation. Clinical evaluation, including QoL assessment with SF-36 questionnaire was performed at the time of initiating therapy with treprostinil, before and 2-9 months after implantation.

NCT ID: NCT02845518 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Study of Cardiac MRI in the Follow up Assessment of Patients With PAH (EVITA)

EVITA
Start date: February 16, 2017
Phase: N/A
Study type: Interventional

Pulmonary arterial hypertension (PAH) is characterized by a progressive increase in pulmonary vascular resistance leading to right ventricular failure and eventually to death. The therapeutic strategy has become complex and needs to perform recurring follow up evaluations including right heart catheterizations (RHC). Cardiac magnetic resonance imaging (cMRI) has the advantage to accurately assess right ventricular volumes and important prognostic predictors such as cardiac index, stroke volume and right ventricular ejection fraction. The main objective of EVITA is to assess the hemodynamic diagnosis performances at baseline and at follow up visits of cMRI in comparison with the results of the RHC (current guidelines) to detect an unfavorable hemodynamic status. The primary endpoint is sensitivity and specificity of cMRI for the diagnosis of an unfavorable status defined by the current RHC criteria (with 95% confidence interval). The secondary objectives are 1) to identify clinical and hemodynamic variables independently contributing to prognosis, 2) to describe complications due to cMRI and to RHC, 3) to compare acceptability and tolerability of cMRI over RHC for the patient, 4) to constitute biological collection of blood samples to determine diagnostic and prognostic PAH biomarkers, 5) To compare the measurements of indexed stroke volume performed by RHC and by cMRI, 6) To evaluate the prognostic value to predict an unfavourable hemodynamic status of cMRI variables (including indexed stroke volume) after taking into account NYHA functional class, 6-minute walk test distance and BNP or NT-proBNP after 4 months of PAH treatment and 7) To evaluate the prognostic value to predict the first occurrence of morbimortality events of cMRI variables (including indexed stroke volume) after taking into account NYHA functional class, 6-minute walk test distance and BNP or NT-proBNP after 4 months of PAH treatment. PAH patients will be recruited in centers of the French network of severe pulmonary hypertension in a prospective cohort study. 180 subjects will be enrolled in the study: that size will give the study 90% power to find significant at the 5%-level. If the primary endpoint were achieved, since first, strategies and procedures planed in this project are consistent with those currently used in routine and second, inclusion criteria are not limited to a sub-population of PAH patients, positive results could allow to broadly extend our findings. Therefore, it will be possible to decrease the number of RHC, an invasive and cumbersome procedure without altering the prognosis. Moreover, all clinical procedures would be performed in outpatient clinics and thereby would reduce the cost to assess the severity of the disease. Current recommendations for evaluation of severity and follow-up being mainly derived from consensus of opinion of the experts, positive results will also improve the level evidence of severity assessment of PAH patients. According to secondary objectives we expect to better predict morbimortality events with cMRI compared to RHC.

NCT ID: NCT02799979 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

3D Imaging: Prognostic Role in Pulmonary Arterial Hypertension

HTP3S
Start date: October 2014
Phase: N/A
Study type: Observational

Pulmonary hypertension is a rare and severe disease, affecting a young population. Survival is very poor and has been closely related to right ventricular dysfunction. Current prognostic equations rely mostly on right heart catheterization data. The identification of simple echocardiographic prognostic factor is urgently needed. It could help identifying with a non invasive method, high risk patients who could benefit from an intensive specific therapy. 3D right ventricular imaging is a new echocardiographic tool which provides RV volumic analysis, RV ejection fraction, overcoming the classical limits of 2D ultrasound. The aim of this study is to validate a new software for 3D analysis of the right ventricle and assess its prognostic role in pulmonary hypertension. To do so, the investigators will realize a prospective monocentric longitudinal cohort study, including 100 pulmonary hypertension patients. Echocardiographic data will be collected at baseline and after 6 months.

NCT ID: NCT02759419 Recruiting - Clinical trials for Hypertension, Pulmonary

A Long-term Extension Study of Riociguat in Patients With Symptomatic Pulmonary Arterial Hypertension.

RIALTO
Start date: June 16, 2016
Phase: Phase 4
Study type: Interventional

To provide riociguat therapy to eligible patients with PAH originating from Bayer-sponsored trials with BAY63-2521/ Riociguat / Adempas® who are currently or recently treated in these trials until lack of patient benefit as assessed by investigator, or commercial availability and reimbursement.

NCT ID: NCT02691689 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Genes Associated With Development of Pulmonary Arterial Hypertension in Patients With Congenital Shunt Lesions

Start date: November 2015
Phase: N/A
Study type: Interventional

Pulmonary arterial hypertension (PAH) in patients with congenital heart disease (CHD) is associated with considerable morbidity and even mortality. Next to environmental risk factors, the investigators believe that there is an important role of genetic predisposition to develop PAH in CHD. There often is a discrepancy between the severity of PAH and the CHD, where it is useful to screen for PAH gene mutations. The investigators hypothesize that the genotype is partly responsible for the phenotypic variability in patients with congenital shunt lesions, where some develop PAH and others do not. If a genetic predisposition for PAH in CHD could be identified, then genetic screening could be a useful additional tool for early detection of patients at risk of pulmonary vascular disease and PAH development, with new opportunities for prevention or early treatment.

NCT ID: NCT02682511 Recruiting - Autoimmune Diseases Clinical Trials

Oral Ifetroban to Treat Diffuse Cutaneous Systemic Sclerosis (SSc) or SSc-associated Pulmonary Arterial Hypertension

Start date: January 2017
Phase: Phase 2
Study type: Interventional

The purpose of this phase 2 multicenter, randomized, double-blind, placebo-controlled, study is to assess the safety and efficacy of ifetroban in patients with diffuse cutaneous systemic SSc (dcSSc) or SSc-associated pulmonary arterial hypertension (SSc-PAH).

NCT ID: NCT02579954 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension

FONCE-HTAP
Start date: August 6, 2015
Phase: N/A
Study type: Interventional

Pulmonary Arterial Hypertension is characterized by a progressive increase in pulmonary vascular resistance inducing shortness of breath and exercise intolerance. We aim to correlate cardiac function (evaluated at rest by right heart catheterism and RMN) to exercise capacity (evaluated by endurance time at 75% of maximal workout), in prevalent patients with pulmonary arterial hypertension, and their evolution at three and twelve months.

NCT ID: NCT02249923 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

Pediatric Pulmonary Hypertension Network (PPHNet) Informatics Registry

PPHNet
Start date: October 2014
Phase:
Study type: Observational [Patient Registry]

Patients are being asked to be in this research study because medical researchers hope that by gathering information about a large number of children with pulmonary hypertension over time, their understanding of the disease process will increase and lead to better treatment. Investigators believe that pulmonary hypertension in children is different than pulmonary hypertension in adults and this study will help us understand those differences.

NCT ID: NCT02207868 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

3D Echo Evaluation of the Ventricles in Sclero Associated Severe PAH

EVA3D
Start date: June 2014
Phase:
Study type: Observational

The aim of the study is to document the left and right ventricular function in patients with sclerodermia associated pulmonal arterial hypertension via 3D echocardiography. The results of this study should help to generate hypothesis for further future studies. The primary hypothesis is that the increased use of modern image guided methods could provide essential aspects for the follow up.

NCT ID: NCT02061787 Recruiting - Clinical trials for Pulmonary Hypertension

the Application of Cardiopulmonary Exercise Testing in Assessment Outcome of Patients With Pulmonary Hypertension

CPETPH
Start date: September 2010
Phase:
Study type: Observational [Patient Registry]

cardiopulmonary exercise test evaluate patients with pulmonary hypertension before and after medical or balloon pulmonary angioplasty treatment